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Lactobacillus Reuteri DSM 17938 in Functional Constipation (LRFC)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier:
NCT01244945
First received: November 17, 2010
Last updated: December 23, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Functional Constipation
 Dietary Supplement: L. reuteri DSM 17938
Other: Placebo Group
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With Functional Constipation

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 72
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L. reuteri DSM 17938 Dietary Supplement: L. reuteri DSM 17938
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 Comparator: Placebo Other: Placebo Group
Placebo tabs identical in form, taste and consistency to active tabs

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244945

Locations
Italy
National Institute for Digestive Diseases IRCCS "S. de Bellis"
Castellana Grotte, Bari, Italy, 70013
Sponsors and Collaborators
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Investigators
Principal Investigator: Giuseppe Riezzo, M.D. Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"
  More Information

Publications:

Responsible Party: Francesco Russo, MD, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
ClinicalTrials.gov Identifier: NCT01244945     History of Changes
Other Study ID Numbers: 1026D
Study First Received: November 17, 2010
Last Updated: December 23, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis:
Functional Constipation
Functional Foods
Probiotics
Lactobacillus reuteri

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013