Nutrition 30 (2014) 1151–1157
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Nutrition journal homepage: www.nutritionjrnl.com
Applied nutritional investigation
Randomized clinical trial: Effect of Lactobacillus plantarum 299 v on symptoms of irritable bowel syndrome e Blaauw Ph.D. a, Cheryl Stevenson M.Sc. a, *, Rene Ernst Fredericks M.B.Ch.B., M.Med., B.Sc.(Hons) b, Janicke Visser M.Nutrition a, Saartjie Roux D.Med.Science b a b
Division of Human Nutrition, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa Department of Biochemistry and Microbiology, Nelson Mandela Metropolitan University, Port Elizabeth, South Africa
a r t i c l e i n f o
a b s t r a c t
Article history: Received 12 October 2013 Accepted 15 February 2014
Objectives: Irritable bowel syndrome (IBS) is a common diagnosis in gastroenterology. Its etiology is unknown and therapeutic options limited. Trials suggest probiotics may be beneficial. The aim of this study was to assess the symptomatic efficacy of Lactobacillus plantarum 299 v (L. plantarum 299 v) for the relief of abdominal pain in patients with IBS fulfilling Rome II criteria. Methods: This study was conducted in a referral hospital. Trial participants were randomized to receive either two capsules of L. plantarum 299 v at a dosage of 5 109 cfu per capsule or placebo daily for 8 wk. Severity of abdominal pain was assessed using a visual analog scale at each visit and a quality-of-life IBS (QoL-IBS) questionnaire was also completed. Results: There was no significant difference in abdominal pain relief between the study and placebo groups (P ¼ 0.800). There was also no difference in QoL- IBS scores between the groups (P ¼ 0.687). Both groups had a significant improvement in abdominal pain scores over the study period, from an average of 251.55 to 197.90 (P < 0.0001) indicating a large placebo effect. Conclusion: An 8-wk treatment with L. plantarum 299 v did not provide symptomatic relief, particularly of abdominal pain and bloating, in patients fulfilling the Rome II criteria. Ó 2014 Elsevier Inc. All rights reserved.
Keywords: Irritable bowel syndrome Probiotics Lactobacillus plantarum 299 v
Background Multiple clinical trials within the past decade have aimed to study the safety and efficacy of various probiotic strains in treating patients with irritable bowel syndrome (IBS). These trials provide guidance to health care professionals as they strive to treat patients suffering with IBS. Both positive and negative trial results provide a way forward and assist in the decisionmaking process. Health care workers are assailed with advertisements, representative details, patient expectations, and questions. Trials that contribute toward completing the picture on the use of specific strains are urgently needed. This study was funded in part by Nestle Nutrition Institute Africa and the South African National Research Foundation, gun number 2075266. CS, RB, EF, JV, and SR designed the research. CS and EF performed the research. CS analyzed the data. All authors helped draft the article. The authors declare they have no competing interests. * Corresponding author. Tel.: þ27 21 938 9259; fax: þ27 21 933 2991. E-mail address:
[email protected] (C. Stevenson). 0899-9007/$ - see front matter Ó 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.nut.2014.02.010
Often, probiotic clinical trials have suffered from inherent design weaknesses. Areas of poor design include Rome criteria not used to define IBS, no randomization, no parallel study design, no double-blinding, no baseline observation period before trial initiation, short treatment duration (
