Lactobacillus Reuteri DSM 17938 in Functional Constipation

NCT01244945 | Completed Phase 4

• 1 other identifier: 1026D
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Constipation

Keywords

Functional Constipation; Functional Foods; Probiotics; Lactobacillus reuteri

Outcome Measures

Primary Outcomes (1)

• Improvement in gastrointestinal symptoms after 3 months of probiotic administration

  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.

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

Secondary Outcomes (2)

• Changes in metabolic parameters after 3 months of probiotic administration

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

• Changes in physiological parameters after 3 months of probiotic administration

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

Study Arms (2)

L. reuteri DSM 17938

EXPERIMENTAL

Dietary Supplement: L. reuteri DSM 17938

Placebo

PLACEBO COMPARATOR

Other: Placebo Group

Interventions

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.

L. reuteri DSM 17938

Placebo Group OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis: lead

Study Sites (1)

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

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (5)

• Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. The effects of probiotics on feeding tolerance, bowel habits, and gastrointestinal motility in preterm newborns. J Pediatr. 2008 Jun;152(6):801-6. doi: 10.1016/j.jpeds.2007.11.005. Epub 2007 Dec 26.

  PMID: 18492520 BACKGROUND

• Russo F, Clemente C, Linsalata M, Chiloiro M, Orlando A, Marconi E, Chimienti G, Riezzo G. Effects of a diet with inulin-enriched pasta on gut peptides and gastric emptying rates in healthy young volunteers. Eur J Nutr. 2011 Jun;50(4):271-7. doi: 10.1007/s00394-010-0135-6. Epub 2010 Oct 12.

  PMID: 20938778 BACKGROUND

• Riezzo G, Clemente C, Leo S, Russo F. The role of electrogastrography and gastrointestinal hormones in chemotherapy-related dyspeptic symptoms. J Gastroenterol. 2005 Dec;40(12):1107-15. doi: 10.1007/s00535-005-1708-7.

  PMID: 16378174 BACKGROUND

• Riezzo G, Chiloiro M, Russo F. Functional foods: salient features and clinical applications. Curr Drug Targets Immune Endocr Metabol Disord. 2005 Sep;5(3):331-7. doi: 10.2174/1568008054863790.

  PMID: 16178793 BACKGROUND

• Valerio F, Russo F, de Candia S, Riezzo G, Orlando A, Lonigro SL, Lavermicocca P. Effects of probiotic Lactobacillus paracasei-enriched artichokes on constipated patients: a pilot study. J Clin Gastroenterol. 2010 Sep;44 Suppl 1:S49-53. doi: 10.1097/MCG.0b013e3181d2dca4.

  PMID: 20495470 BACKGROUND

Study Officials

• Giuseppe Riezzo, M.D.

  Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 22, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

IT (1)