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ProVen Probiotics'
own research

Dedicated to supporting the efficacy and effectiveness of our product range.

ProVen clinical
trials

As part of Cultech Ltd, the bioscience company based in South Wales in the UK, ProVen Probiotics has access to a team of around 15 research scientists who have been committed to research of the microbiome and probiotics for more than 30 years and are continuously involved in clinical research and product development.

Owned by Dr Nigel Plummer, Cultech and ProVen are both research-led companies, ProVen having been established to bring research-backed probiotics products to the general public to help support their microbiome and thus their health. We now have more than 100 published articles, research papers and posters related to the gut, the microbiome and Lab4 probiotics (the proprietary group of bacteria contained in most of our products).

The products developed for the ProVen Probiotics range are all based upon clinical research into the specific blends of bacteria used in the products. Summaries of and links to the studies are included below.

2021

The PROBE Study

A 9-month randomised, double-blind, placebo-controlled study assessed the impact of Lab4P probiotic supplementation on body weight. Seventy overweight participants aged 45–65 years with BMI 25–29.9 received a daily dose of either 50 billion Lab4P probiotics or a matching placebo with no other changes to their diet or lifestyle over a study period. Lab4P probiotic supplementation for 9 months significantly reduced bodyweight by 3.76% in overweight adults compared to placebo. 40% of participants in the Lab4P group reached the desirable annual 5% weight loss beneficial for health and wellbeing. The significant reductions in BMI, waist circumference and hip circumference were also found. In conclusion, the supplementation with Lab4P is beneficial in the weight management and the findings of this study support the outcomes of a previous PROMAGEN study with 220 overweight and obese participants.
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The ProChild-2 Study

The second long-term randomised, double-blind, placebo-controlled study investigated the effect of Lab4 probiotics in combination with low dose of vitamin C in the prevention of coughs and colds. 171 children aged 3 to 10 years received daily either a chewable tablet containing the 12.5 billion Lab4 probiotics plus 50 mg vitamin C or a matching placebo for 6 months. The Lab4 probiotics in combination with low dose of vitamin C significantly reduced the incidence of coughing and sore throats compared to placebo. The incidence of absence from school was significantly reduced by 16% in children taking Lab4/vitamin C combination together with 19% reduction in the number of visits to the G.P and 27% reduction in the antibiotic usage. Our two probiotic studies (ProChild and ProChild-2) with the same intervention for same duration showed the beneficial effect in the management of coughs and colds in children attending preschool/school.
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2020

The PROMAGEN Study

The randomised, double-blind, placebo-controlled study aimed to assess the effect of 6-month supplementation with the Lab4P probiotic on body weight, cholesterol levels, coughs and colds and well-being in healthy overweight and obese individuals. 220 adults aged 30-65 years with BMI 25-34.9 received a daily dose of either 50 billion Lab4P probiotics or a matching placebo with no other changes to their diet or lifestyle throughout the study period. The Lab4P probiotic supplementation significantly reduced bodyweight by 1.5% in the overweight and obese adults. Greater reduction in bodyweight loss was observed in the overweight adults (1.9%), adults over 50 years old (2%) and adults with high cholesterol levels (2.5%). The levels of atherogenic small dense LDL (‘bad’) cholesterol were significantly reduced in response to the Lab4P probiotics. The 40% reduction was observed in the incidence of total coughs and colds symptoms, together with the improvements in Quality of Life scores of general wellness, health, energy and mood. Lab4P probiotics demonstrated a protective role in reducing the incidence of viral specific upper respiratory tract infection symptoms particularly in older or obese adults and preventing changes in gut microbiota composition in the older participants who developed URTI symptoms (2021 publication). In conclusion, the supplementation with Lab4P probiotics is beneficial in the weight management, immune support and quality of life.
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The Cycling Endurance Study

The aim of this double-blind placebo-controlled crossover study was to investigate whether Lab4 probiotic supplementation increases the use of an ingested carbohydrate drink (main fuel source for muscle) during 2 hours of cycling exercise at 55% maximal aerobic power output. Seven trained cyclists received a daily dose of either 25 billion Lab4 probiotics or a matching placebo for 28 days. After 28 days of supplementation, the cyclists took their additional supplement dose on the morning of the trial (1 hour before exercise) and underwent 2 hours of cycling at 55% maximal workload, followed by an exercise simulating the final sprint in a competitive, long distance road race. During exercise participants consumed 10% carbohydrate drink (maltodextrin and labelled glucose). Following a 14-day washout period, the cyclists who took a placebo in the first 28 days received 25 billion Lab4 probiotics and vice versa. After 28 days of supplementation and an additional supplement dose prior trial, the participants repeated the same cycling exercise. The cyclists taking Lab4 probiotics for 4 weeks were able to oxidise (use) more of orally ingested carbohydrates during the cycling endurance exercise, whereas fat oxidation was reduced.
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2019

The Marathon Endurance Study

This randomised, double-blind, placebo-controlled study was designed to evaluate the effect of Lab4 probiotic supplementation on gut symptoms, race time, intestinal permeability and immunological markers during marathon training and racing. Twenty-four recreational runners took a daily dose of either 25 billion Lab4 probiotics or a matching placebo for 28 days prior to a marathon race. After 4 weeks of supplementation, the runners received an additional dose on the morning of the race undertook the 42.195 km marathon race on a synthetic 400m outdoor track. The marathon runners taking Lab4 probiotics experienced fewer and less severe gut symptoms during their training period and marathon race. The reduction in gut symptoms was associated with maintaining running speed during the latter stages of the race. Protective effect of Lab4 probiotics was observed on the metabolic perturbations induced by marathon (2021 publication). In conclusion, the Lab4 probiotic supplementation may be beneficial in maintaining the integrity of the gut during endurance exercise.
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2017

The Ultra Marathon Endurance Study

The aim of this study was to investigate the effect of Lab4 probiotic supplementation before and after an ultra-marathon. Thirty-two Marathon des Sables competitors were divided into three groups and received a daily dose of either 30 billion Lab4 probiotics or a combination of 5 billion Lab4 probiotics, 5 billion Lactobacillus salivarius CUL61 and 0.9 g L-glutamine or were asked to maintained their regular diet. After 12 weeks supplementation, the runners undertook the Marathon des Sables (294.4 km, 7-day ultra-marathon, across the Southern Moroccan portion of Sahara Desert, max temperature 39°C). The supplementation with Lab4 probiotics resulted in 12% reduction in runners’ completion time during the ultra-marathon race. No differences in the extracellular heat shock protein (eHsp72) concentration were observed between groups during the study period.
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2016

The Hertfordshire Study

This randomised, double-blind, placebo-controlled study aimed to assess the impact of Lab4 probiotic/prebiotic/antioxidant intervention on gut symptoms, endotoxin levels, intestinal permeability and race time in recreational athletes. Thirty recreationally active volunteers went through a 9-month standardized training programme and in their final 12 weeks of the training received daily either 30 billion Lab4 probiotics with prebiotic fibre or 30 billion Lab4 probiotics with prebiotic fibre and antioxidants or a placebo. After 12 weeks, the athletes undertook Barcelona Challenge Triathlon (3.8 km sea swim, 180 km road cycle and 42.2 km marathon). The triathlon athletes taking Lab4 probiotics with prebiotic fibre alone or in combination with antioxidants experienced fewer and less severe exercise- related gut symptoms during their training period. The reductions in plasma endotoxin levels were observed with Lab4 probiotic/fibre/antioxidant supplementation. The Lab4 probiotic with fibre supplementation led to faster race finishing times. In conclusion, Lab4 probiotics with fibre alone or in combination with antioxidants protect athletes from gut disturbances during endurance training and improve their race finishing times.
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2015

The ProChild Study

This randomised, double-blind, placebo-controlled study aimed to show that the Lab4 probiotics in combination with vitamin C had the capability of significantly reducing the symptoms of coughs and colds in young children, who are most susceptible age group. Fifty-seven children aged 3-6 years received daily for 6 months either a chewable tablet containing the 12.5 billion Lab4 probiotics plus 50 mg Vitamin C or a matching placebo. The Lab4 probiotics in combination with low dose of vitamin C significantly reduced the incidence (by 33%) and duration (by 49%) of colds and coughs together with a significant reduction in the use of cough medicine. The incidence of absence from preschool was significantly reduced by 30%. In conclusion, the supplementation with Lab4 probiotics and low dose vitamin C combination is beneficial in the prevention and management of coughs and colds.
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2014

The Swansea Baby Study

This large randomised, double blind, placebo-controlled study was designed to evaluate whether Lab4B probiotics given during pregnancy and infancy are safe and could prevent allergy in children. 454 mother/baby pairs received daily either 10 billion Lab4B probiotics or a matching placebo in the last trimester of pregnancy and for the first six months of infancy. The babies given Lab4b probiotics from birth were 57% less likely to develop atopic eczema than those receiving the placebo. Development of atopic sensitisation (reaction) to common allergens (pollen, cow’s milk, egg and house dust mite) was significantly reduced by 44% with Lab4b supplementation. Constipation occurred in fewer infants supplemented with Lab4b probiotics. The primary author, Prof. Steve Allen, concluded the following key message from the trial… ‘Lactobacilli and Bifidobacteria administered to pregnant women and infants aged 0-6 months prevented atopic sensitization and atopic eczema.’
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The Running to Exhaustion Study

This randomised, double-blind, placebo controlled cross-over study aimed to investigate the effect of Lab4 based multi-strain probiotics on gut permeability, inflammation and running performance when exercising in the heat. Ten trained runners received daily for 4 weeks either 45 billion Lab4 based multi-strain probiotics or a matching placebo. After 4 weeks, the runners completed the time-to-fatigue run (80% ventilatory threshold, 35C, 40% relative humidity). Following a 3-week washout period, the runners who took a placebo in the first 4 weeks received Lab4 based multi-strain probiotics and vice versa. After 4 weeks of supplementation, the participants repeated the same time-to-fatigue run. The runners supplemented with Lab4 based multi-strain probiotics exercised for a longer period and their running time to exhaustion in heat was significantly increased. The reduction in gut permeability was observed with probiotic supplementation.
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The Keele Study

This randomised, double blind, placebo-controlled study examined the effects of Lab4 probiotics on general feelings of anxiety, mood and cognitive function in healthy individuals. Fifty healthy volunteers received a daily dose of either 50 billion Lab4 probiotics or a matching placebo for 6 weeks. Healthy adults supplemented with Lab4 probiotics experienced reduced anxiety in response to the anticipation of a future threat. The ability to focus and avoid any distraction was significantly increased with Lab4 probiotics. In conclusion, the study showed the benefit of Lab4 probiotics for cognitive function in healthy individuals.
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2013

The Cambridge Study

This study assessed the effect of Lab4 probiotics on the composition of microbiota in IBS sufferers receiving antibiotic therapy. Twelve IBS sufferers took daily either 25 billion Lab4 probiotics or a matching placebo for 7 days prior to antibiotics and during the antibiotic treatment (7 days). The overgrowth of yeasts was observed following antibiotic therapy in IBS sufferers. Detection of yeasts was reduced with supplementation of Lab4 probiotics prior to and alongside antibiotics. Reference: Plummer S et al. Effects of probiotics on the caecal and faecal microbiota of Irritable Bowel Syndrome patients receiving antibiotics: a pilot study. Short Communication. ENGIHR, Valencia, Spain, 18-20th September 2013, pg183-6.
Read More Here

The Adult Immune Study

This study examined the effect of Lab4 probiotics on the immune health profile of healthy adults by assessment of ex vivo cytokine production. Twenty participants received daily 25 billion Lab4 probiotics with 2g of fructooligosaccharide (FOS) for 12 weeks. The supplementation with Lab4 probiotics in combination with prebiotic fibre resulted in significant increase of ex vivo anti-inflammatory cytokine production and reduction in production of the pro-inflammatory cytokine demonstrating the potential immunomodulatory benefits.
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2010

The Safety in Newborns Study

The 454 mother/baby pairs in the randomised, double-blinded, placebo-controlled Swansea Baby Study were assessed for adverse events when taking Lab4B probiotics. The supplementation with Lab4B probiotics was well tolerated and safe for mums-to-be and their healthy newborn babies.
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2009

The Cardiff Tracking Study

This study evaluated if the colony fingerprint technique (RAPD) could be used to track probiotics Lactobacillus acidophilus CUL21 and Lactobacillus salivarius CUL61 during consumption by healthy volunteers. Twelve participants received one capsule of 18 billion L. salivarius CUL61 and 5.6 billion L. acidophilus CUL21 once a day for 14 days. Probiotic strains Lactobacillus acidophilus CUL21 (from Lab4 probiotic blend) and Lactobacillus salivarius CUL61 (from Lab4B probiotic blend) survived passage through gastrointestinal tract during probiotic consumption and were detected in the stool samples of healthy volunteers.
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2008

The Sheffield IBS Study

This randomised, double-blind, placebo-controlled study investigated the effect of Lab4 probiotics on the symptoms of irritable bowel syndrome (IBS). Fifty-two IBS sufferers received a daily dose 25 billion Lab4 probiotics or a matching placebo for 8 weeks. The IBS symptoms were assessed every two weeks during the study period and again at 10 weeks – two weeks after taking the probiotics. Total IBS Symptoms included the number of days with pain, level of abdominal pain, bloating, quality of life and satisfaction with bowel habit. The Lab4 probiotics significantly reduced total symptoms and improved quality of life in IBS sufferers. The continued Lab4 probiotic supplementation appears to be necessary to sustain the benefits.
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2005

The Cambridge Probiotic Antibiotic Trial 1

This randomised, double blind, placebo-controlled study investigated the effect of Lab4 probiotics on the gut microbiota composition and prevention of pathogenic microorganisms’ overgrowth in response to antibiotic therapy. Twenty-two patients required antibiotics took daily for 15 days either 25 billion Lab4 probiotics or a matching placebo alongside antibiotics (same day) or after antibiotic course. The numbers of facultative anaerobes remained stable in patients taking Lab4 probiotics alongside antibiotics. The overgrowth population of coliforms, enterococci and staphylococci in the gut re-growth microbiota was reduced post antibiotic therapy. In conclusion, the supplementation of Lab4 probiotics alongside antibiotic therapy has been shown to reduce the overgrowth of undesirable and potentially harmful bacteria.
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The Cambridge Probiotic Antibiotic Trial 2

This randomised, double blind, placebo-controlled study investigated the effect of Lab4 probiotics on the antibiotic resistance in the gut re-growth microbiota following antibiotic therapy. 155 patients required antibiotics received a daily dose of either 25 billion Lab4 probiotics or a matching placebo for 21 days. The Lab4 probiotic supplementation alongside antibiotics significantly reduced the numbers of Candida albicans at the end of antibiotic therapy. The numbers of facultative anaerobes and enterobacteria were significantly reduced four weeks post antibiotic therapy. The incidence rate of enterococci antibiotic resistance post antibiotic therapy increased in the placebo group, but there was no change among patients in the Lab4 probiotic group. In conclusion, the supplementation of Lab4 probiotics alongside antibiotic therapy has been shown to reduce the extent of gut microbiota disruption and to reduce the level of antibiotic resistance within the ‘re-growth’ microbiota.
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2004

The Cambridge Clostridium difficile Study

This randomised, double-blind, placebo-controlled study examines the role of Lab4 probiotics in the prevention of Clostridium difficile-associated diarrhoea (CDAD) in patients receiving antibiotic therapy. 138 elderly patients received daily either 25 billion Lab4 probiotics or a matching placebo in conjunction with their prescribed antibiotics for 20 days. Lab4 probiotics reduced the incidence of Clostridium difficile diarrhoea. 46% of patients supplemented with Lab4 probiotics were positive for Clostridium difficile toxin compared to 78% of patients in the placebo group. In conclusion, the supplementation with Lab4 probiotics may reduce the incidence of Clostridium difficile diarrhoea in hospitalised patients.
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† THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.

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