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Lactobacillus Reuteri DSM 17938 in Functional Constipation (LRFC)

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ClinicalTrials.gov Identifier: NCT01244945
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Tracking Information
First Submitted Date  ICMJE November 17, 2010
First Posted Date  ICMJE November 22, 2010
Last Update Posted Date March 27, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
  • Improvement in gastrointestinal symptoms evaluated by validated questionnaires 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.
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2011)
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lactobacillus Reuteri DSM 17938 in Functional Constipation
Official Title  ICMJE Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With Functional Constipation
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Functional Constipation
Intervention  ICMJE
  • 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.
  • Other: Placebo Group
    Placebo tabs identical in form, taste and consistency to active tabs
Study Arms  ICMJE
  • Experimental: L. reuteri DSM 17938
    Intervention: Dietary Supplement: L. reuteri DSM 17938
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo Group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2010)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01244945
Other Study ID Numbers  ICMJE 1026D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Original Responsible Party Dr. Giuseppe Riezzo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Current Study Sponsor  ICMJE Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giuseppe Riezzo, M.D. Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"
PRS Account Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP