- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01244945
Lactobacillus Reuteri DSM 17938 in Functional Constipation (LRFC)
26. mars 2014 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
72
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Bari
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Castellana Grotte, Bari, Italia, 70013
- National Institute for Digestive Diseases IRCCS "S. de Bellis"
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
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Placebo tabs identical in form, taste and consistency to active tabs
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Improvement in gastrointestinal symptoms after 3 months of probiotic administration
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes in metabolic parameters after 3 months of probiotic administration
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Giuseppe Riezzo, M.D., Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2011
Primær fullføring (Faktiske)
1. desember 2013
Studiet fullført (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først innsendt
17. november 2010
Først innsendt som oppfylte QC-kriteriene
19. november 2010
Først lagt ut (Anslag)
22. november 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. mars 2014
Sist bekreftet
1. mars 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1026D
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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