- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01244945
Lactobacillus Reuteri DSM 17938 in Functional Constipation (LRFC)
26 mars 2014 uppdaterad av: Francesco Russo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
72
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bari
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Castellana Grotte, Bari, Italien, 70013
- National Institute for Digestive Diseases IRCCS "S. de Bellis"
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
19 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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Placebo tabs identical in form, taste and consistency to active tabs
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Experimentell: L. reuteri DSM 17938
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Improvement in gastrointestinal symptoms after 3 months of probiotic administration
Tidsram: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
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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.
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Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Changes in metabolic parameters after 3 months of probiotic administration
Tidsram: Before the start of the study (time 0) and after 90 days of treatment (Time 90)
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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.
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Before the start of the study (time 0) and after 90 days of treatment (Time 90)
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Changes in physiological parameters after 3 months of probiotic administration
Tidsram: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
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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
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Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Giuseppe Riezzo, M.D., Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2011
Primärt slutförande (Faktisk)
1 december 2013
Avslutad studie (Faktisk)
1 januari 2014
Studieregistreringsdatum
Först inskickad
17 november 2010
Först inskickad som uppfyllde QC-kriterierna
19 november 2010
Första postat (Uppskatta)
22 november 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 mars 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 mars 2014
Senast verifierad
1 mars 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1026D
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