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Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating.
Am J Gastroenterol 2017; 112(1):145-151AJ

Abstract

OBJECTIVES

Bifidobacterium infantis 35624 is a probiotic that is used often in patients with irritable bowel syndrome (IBS). Non-patients with bowel symptoms may differ from patients with IBS in the impact of their bowel symptoms on illness severity, healthcare and treatment seeking behavior. The aim of this study is to assess the efficacy of B. infantis 35624 (109 c.f.u. per day) for the relief of abdominal discomfort and bloating in a non-patient population.

METHODS

A double-blind, randomized, placebo-controlled, parallel study with a 2-week placebo run-in phase followed by a 4-week intervention phase was conducted at ten clinical centers (USA). Subjects were recruited from the general population by advertisement. The study randomized 302 subjects who experienced abdominal discomfort and bloating ≥2-times per week for at least three months but have not seen a physician or received prescribed medication for their symptoms in the past 12 months. Subjects were assessed for pre- to post-intervention changes in symptom severity (on a 6-point Likert scale; 0=none, 5=very severe) and frequency (symptoms-free days).

RESULTS

A total of 275 subjects (mean age 42 years, 79% female, 74% Caucasian) provided evaluable data. Overall mean severity scores at baseline were 2.4 for abdominal discomfort and 2.5 for bloating with no significant differences between the placebo and probiotic groups. Both groups showed significant (P<0.05) improvement in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at the end of intervention showed no significant differences between the probiotic and the placebo groups in either abdominal discomfort or bloating (P>0.3). The frequency of abdominal bloating-free days was greater in the B. infantis 35624 group compared to the placebo group (P<0.05). Both regimens were well tolerated.

CONCLUSIONS

Unlike previous clinical studies in patients with IBS, B. infantis 35624 did not show a significant improvement in the mean severity of symptoms of abdominal discomfort and bloating in a non-patient population. This may be explained by the high placebo effect and the lower impact of functional bowel symptoms in the non-patient population.

Authors+Show Affiliations

Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.The Procter & Gamble Company, Mason, Ohio, USA.School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. Department of Gastroenterology, Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27845337

Citation

Ringel-Kulka, Tamar, et al. "Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium Infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating." The American Journal of Gastroenterology, vol. 112, no. 1, 2017, pp. 145-151.
Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017;112(1):145-151.
Ringel-Kulka, T., McRorie, J., & Ringel, Y. (2017). Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. The American Journal of Gastroenterology, 112(1), pp. 145-151. doi:10.1038/ajg.2016.511.
Ringel-Kulka T, McRorie J, Ringel Y. Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium Infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. Am J Gastroenterol. 2017;112(1):145-151. PubMed PMID: 27845337.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. AU - Ringel-Kulka,Tamar, AU - McRorie,Johnson, AU - Ringel,Yehuda, Y1 - 2016/11/15/ PY - 2016/03/18/received PY - 2016/09/15/accepted PY - 2016/11/16/pubmed PY - 2017/6/21/medline PY - 2016/11/16/entrez SP - 145 EP - 151 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 112 IS - 1 N2 - OBJECTIVES: Bifidobacterium infantis 35624 is a probiotic that is used often in patients with irritable bowel syndrome (IBS). Non-patients with bowel symptoms may differ from patients with IBS in the impact of their bowel symptoms on illness severity, healthcare and treatment seeking behavior. The aim of this study is to assess the efficacy of B. infantis 35624 (109 c.f.u. per day) for the relief of abdominal discomfort and bloating in a non-patient population. METHODS: A double-blind, randomized, placebo-controlled, parallel study with a 2-week placebo run-in phase followed by a 4-week intervention phase was conducted at ten clinical centers (USA). Subjects were recruited from the general population by advertisement. The study randomized 302 subjects who experienced abdominal discomfort and bloating ≥2-times per week for at least three months but have not seen a physician or received prescribed medication for their symptoms in the past 12 months. Subjects were assessed for pre- to post-intervention changes in symptom severity (on a 6-point Likert scale; 0=none, 5=very severe) and frequency (symptoms-free days). RESULTS: A total of 275 subjects (mean age 42 years, 79% female, 74% Caucasian) provided evaluable data. Overall mean severity scores at baseline were 2.4 for abdominal discomfort and 2.5 for bloating with no significant differences between the placebo and probiotic groups. Both groups showed significant (P<0.05) improvement in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at the end of intervention showed no significant differences between the probiotic and the placebo groups in either abdominal discomfort or bloating (P>0.3). The frequency of abdominal bloating-free days was greater in the B. infantis 35624 group compared to the placebo group (P<0.05). Both regimens were well tolerated. CONCLUSIONS: Unlike previous clinical studies in patients with IBS, B. infantis 35624 did not show a significant improvement in the mean severity of symptoms of abdominal discomfort and bloating in a non-patient population. This may be explained by the high placebo effect and the lower impact of functional bowel symptoms in the non-patient population. SN - 1572-0241 UR - https://www.unboundmedicine.com/medline/citation/27845337/Multi_Center_Double_Blind_Randomized_Placebo_Controlled_Parallel_Group_Study_to_Evaluate_the_Benefit_of_the_Probiotic_Bifidobacterium_infantis_35624_in_Non_Patients_With_Symptoms_of_Abdominal_Discomfort_and_Bloating_ L2 - http://Insights.ovid.com/pubmed?pmid=27845337 DB - PRIME DP - Unbound Medicine ER -