Beyond Biotics Clinical Studies

Click the links below to review the Clinical Studies that support the benefits from Beyond Biotics™:

Probiotics in The Treatment of Irritable Bowel Syndrome

Saggioro, Alfredo MD, Journal of Clinical Gastroenterology: July 2004 - Volume 38 - Issue - pp S104-S106.

Irritable Bowel Syndrome (IBS) may be diagnosed on the presence of symptoms, according to Rome II criteria and some studies have shown that abnormal colonic fermentation may be an important factor in the development of symptoms in some patients with IBS. Since the fermentations of substrates by the intestinal flora may play a key role in the use of probiotics in the treatment of IBS, fifty patients (24 males,26 females), mean age 40 years (range = 26–64 years) with IBS, according to Rome II criteria, were enrolled into the study after informed consensus. Patients were randomly assigned to receive either the active preparation containing Lactobacillus Plantarum LP0 1 and Bifidocterium Breve BR0 both at a concentration of 5 × 109 CFU/ml, or placebo powder containing starch identical to the study product, for 4 weeks. To evaluate treatment efficacy two different scores were considered: Pain score in different abdominal locations after treatment decreased in probiotics group of 38% versus 18% (P < 0.05) of placebo group after 14 days and of 52% versus 11% (P < 0.001) after 28 days. The severity score of characteristic IBD symptoms significantly decreased in probiotic group versus placebo group after 14 days 49.6% versus 9.9% (P < 0.001) and these data were confirmed after 28 days (44.4% versus 8.5%, P < 0.001). In conclusion, short-term therapy with Lactobacillus PlantarumLP0 1 and Bifidocterium Breve BR0 may be considered a promising approach to the therapy for IBS.

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The Use of Probiotics in Healthy Volunteers With Evacuation Disorders and Hard Stools: A Double-blind, Randomized, Placebo-controlled Study

Del Piano, Mario MD; Carmagnola, Stefania MD; Anderloni, Andrea MD; Andorno, Silvano MD; Ballarè, Marco MD; Balzarini, Marco MD; Montino, Franco MD; Orsello, Marco MD; Pagliarulo, Michela MD; Sartori, Massimo MD; Tari, Roberto MD; Sforza, Filomena MD; Capurso, Lucio MD: Journal of Clinical Gastroenterology, September 2010 - Volume 44 - Issue - pp S30-S34.

Background: Evacuation disorders and hard stools are common in industrialized countries, affecting on average 12% to 17% of the adult healthy population at any age. Dietary supplementation with probiotic microorganisms may be useful in reducing the disorder.

Methods: We performed a double-blind, randomized, placebo-controlled study to evaluate the effectiveness of 2 different probiotic blends, either mixed Lactobacillus plantarum LP01 (LMG P-21021) and Bifidobacterium breve BR03 (DSM 16604) or Bifidobacterium animalis subspecies lactis BS01 (LMG P-21384), in the management of evacuation disorders and intestinal discomfort. In a period of 5 years (2003 to 2008), the study involved 300 healthy volunteers (151 males and 149 females; age 24 to 71 y) with evacuation disorders and hard stools. In particular, subjects were divided into 3 groups: 80 subjects in the group A received placebo, 110 subjects in the group B received mixed L. plantarum LP01 and B. breve BR03 (2.5×109 colony-forming units/d of each strain), and 110 subjects in the group C received B. animalis subsp. lactis BS01 (5×109 colony-forming units/d) for 30 days. At the beginning of the observational study, the healthy status of volunteers was evaluated by a complete, laboratory and ultrasound study of the abdomen. The physical examination was repeated after 15 and 30 days. In particular, the main troubles typically associated with evacuation disorders and hard stools as well as abdominal bloating were considered as parameters of interest. Exclusion criteria were items of gastrointestinal diseases and antibiotics intake.

Results: Subjects treated with the mixed probiotic strains L. plantarum LP01 and B. breve BR03 or B. animalis subsp. lactis BS01 reported a significant improvement in the number of weekly bowel movements and in the main troubles associated with evacuations, particularly consistency of feces and ease of expulsion. Discomfort items such as abdominal bloating and anal itching, burning, or pain also registered a relevant improvement in the active groups receiving probiotics.

Conclusions: The intake of an effective amount of mixed L. plantarum LP01 and B. breve BR03 or B. animalis subsp. lactis BS01 for 30 days is able to significantly relieve the evacuation disorders and hard stools, thus providing a useful tool for the management of such condition, which is particularly widespread in industrialized countries at any age.

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Probiotic supplementation for respiratory and gastrointestinal illness symptoms in healthy physically active individuals

Nicholas P West, Peggy L Horn, David B Pyne, Val J Gebski4, Sampo J Lahtinen, Peter A Fricker, Allan W Cripps: Clinical Nutrition, Volume 33, Issue 4, August 2014, Pages 581–587.

Background & Aims: To examine the effect of supplementation with probiotics on respiratory and gastrointestinal illness in healthy active men and women.

Methods: A randomised double-blind placebo-controlled trial was conducted. Four hundred and sixty five participants (241 males; age 35 ± 12 y (mean ± SD) and 224 females; age 36 ± 12 y) were assigned to one of three groups: Group 1 – Bifidobacterium animalis subsp. lactis Bl-04 (Bl-04) 2.0 × 109colony forming units per day, CFU per day, Group 2 – Lactobacillus acidophilus NCFM and Bifidobacterium animalis subsp. lactis Bi-07 (NCFM & Bi-07) 5 × 109 CFU each per day) or Group 3 – placebo mixed in a drink.

Results: The risk of an upper respiratory illness episode was significantly lower in the Bl-04 group (hazard ratio 0.73; 95% confidence interval 0.55–0.95; P = 0.022) compared to placebo. There was no significant difference in illness risk between the NCFM & Bi-07 group (hazard ratio 0.81; 0.62–1.08; P = 0.15) and the placebo group. There was a 0.7 and 0.9 month delay in the median time to an illness episode in the Bl-04 and NCFM & Bi-07 groups respectively compared to placebo (placebo 2.5 months; Bl-04 3.2 months; NCFM & Bi-07 3.4 months). There were insufficient GI illness episodes for analysis. The NCFM & Bi-07 group but not the Bl-04 group undertook significantly more physical activity (8.5%; 6.7%–10%; P < 0.003) than the placebo group.

Conclusion: The probiotic Bl-04 appears to be a useful nutritional supplement in reducing the risk of URTI in healthy physically-active adults.

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