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Completed

NCT Number: NCT01244945

Lactobacillus Reuteri DSM 17938 in Functional Constipation

The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the last century in western countries. In the USA and Northern Europe, constipation is twofold the prevalence found in the East and Southern Europe. In Italy, constipation affects up to 15-17% of the whole adult population. Of them, more than half (about 10%) treats this disorder by assuming laxatives, while the remaining does not even assume drugs. A close relationship between intestinal environment and bacterial flora has been found. As a matter of fact changes in the intestinal physiology can modify the composition of bacterial flora as well as modifications in the intestinal microbiota can modify the physiology of the gut. The probiotic effects on the GI motility can be due to substances released by bacteria and/or products of their fermentation. Also, probiotic may indirectly act by the release of neuroendocrine factors and/or substances released by the immune system. Clinically, it has already been demonstrated that probiotics exert a positive effect on symptoms and intestinal habit in constipated IBS patients. In this framework, the idea to perform a long lasting intervention study in patients with functional constipation treated with probiotics sounds convincing. The present study is a randomized, double blind, placebo controlled, monocentric study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria. Clinical, physiological, hematological and immunologic variables will be evaluated.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute for Digestive Diseases IRCCS "S. de Bellis"

Castellana Grotte, Bari, 70013, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fulfilment of the Rome Criteria III for functional constipation
  • Availability of at least one GI imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)
  • Commitment to availability for the whole study period

Exclusion criteria

  • Major abdominal surgery
  • Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness
  • Alarming symptoms (rectal bleeding, weight loss, etc)
  • Family history of peptic ulcer, colorectal cancer, or IBD
  • Abnormal laboratory data or thyroid function.

Treatment and study plan

L. reuteri DSM 17938

Dietary Supplement

L. reuteri will be administered at 1x10^8 CFU dosage in form of tabs. In order to ensure colonization (run in), 4 tabs will be administered per os daily (4x10^8CFU/die) for 15 days. Then administration will continue with 2 tabs daily (2x10^8 CFU/die) for 90 days.

Placebo Group

Other

Placebo tabs identical in form, taste and consistency to active tabs

Primary outcomes

  1. Improvement in gastrointestinal symptoms after 3 months of probiotic administration

    Time frame: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)

    Validated and structured questionnaires to evaluate gastrointestinal symptoms, to confirm functional constipation diagnosis and to exclude IBS variant constipation. Score of gastrointestinal symptoms with Gastrointestinal Symptom Rating Score (GSRS); Constipation Symptom Score (CSS); Constipation QoL, Constipation Rome criteria, Diary for the symptoms and for intestinal behavior. These questionnaires will be administered at baseline, after 45 days of treatment, and at the end of treatment.

Secondary outcomes

  1. Changes in metabolic parameters after 3 months of probiotic administration

    Time frame: Before the start of the study (time 0) and after 90 days of treatment (Time 90)

    Lipidic and glucidic profile; evaluation of circulating immunological parameters, short chain fatty acid (SCFA)faecal concentrations. The evaluations will be performed at baseline, after 45 days of treatment and at the end of treatment.

  2. Changes in physiological parameters after 3 months of probiotic administration

    Time frame: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)

    Physiological parameters: Quali/Quantitative evaluation of the colonic transit time (TTC) with radiopaque markers (qualitative study : RX after 3 days from the 20 markers assumption. Quantitative study: RX after 3 days from the assumption of 10 markers a day for 6 days in patients with TTC delayed), non invasive evaluation of gastric electrical activity and gastric emptying time (cutaneous electrography (EGG) and 13C octanoic acid breath test). The evaluations will be performed at baseline, after 45 days of treatment and at the end of treatment

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Other

Registry information

Official study title

Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With Functional Constipation

Acronym: LRFC

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 22, 2010
Registry last updated
Mar 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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