AzTrials
AzTrials

Functional ConstipationPhase 4LRFCNCT01244945

Lactobacillus Reuteri DSM 17938 in Functional Constipation

A Phase 4 study testing L. reuteri DSM 17938 in people with Functional Constipation, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Functional Constipation
What is being tested?
L. reuteri DSM 17938
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteItaly
Study dates
Jan 2011to Jan 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Castellana Grotte, Bari, 70013

Other trials in Italy

About this study

Official title: Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With 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.

Being tested
L. reuteri DSM 17938, Placebo Group
Keywords
Functional Constipation, Functional Foods, Probiotics, Lactobacillus reuteri

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • L. reuteri DSM 17938Dietary supplement

    1. 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 GroupOther

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

Study groups in NCT01244945
Study groupRoleWhat they receive
L. reuteri DSM 17938ExperimentalNot described
Receives: Dietary Supplement: L. reuteri DSM 17938
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

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

    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.

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

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

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionDec 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01244945
Sponsor's protocol ID
1026D
Acronym
LRFC
Status last verified
Mar 2014
First submitted
17 Nov 2010
Last updated
27 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18492520

  • 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.

    PubMed 20938778

  • 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.

    PubMed 16378174

  • 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.

    PubMed 16178793

  • 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.

    PubMed 20495470

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing L. reuteri DSM 17938 in people with Functional Constipation, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01244945, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in