Effect of a Fermented Milk Product With Probiotics Alone or in Combination With Fibers on Constipation Symptoms
21. august 2017 opdateret af: Danone Research
Evaluation of Effects of Fermented Dairy Products Containing Probiotics Alone or in Association With Fibers on Bowel Functions, Constipation Symptoms and Health Related Quality of Life in Adult Subjects With Moderate Constipation: an Exploratory Randomized Double-blind, Controlled Adaptive Study
First experimental study (Proof Of Concept) to investigate bowel function parameters on which a fermented milk product with probiotics alone or in association with fibers has a potential effect.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
153
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Cork, Irland
- Atlantia Food Clinical Trials
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 69 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Main eligibility criteria (non-exhaustive list) are defined as:
- Healthy Caucasian subject of both gender, aged from 18 to 69 years
- Subject with body mass index (BMI) between 18 kg/m2 (bound included) and 30 kg/m2 (bound excluded)
- Subjects with moderate constipation defined according to ROME III adapted criteria.
- Subjects without ongoing or diagnosed gastrointestinal disease or complications.
- Subjects without previous (within one month), ongoing or planned therapy during the study with drugs altering bowel function.
- Subjects without known gluten intolerance, lactose intolerance or allergy to milk proteins.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1=BOW_01
1= Fermented Milk Product containing Probiotics
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2 pots/day during 28 days
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Eksperimentel: 2=BOW_01 + fiber C
2= Fermented Milk Product containing Probiotics + Fibers C
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2 pots/day during 28 days
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Eksperimentel: 3 =BOW_01 + fiber W
3= Fermented Milk Product containing Probiotics + Fibers W
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2 pots/day during 28 days
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Placebo komparator: 4 = Control
4= Non fermented Milk Product with same color, texture and organoleptic properties as investigational products 1 to 3.
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2 pots/day during 28 days
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change in frequency of spontaneous bowel movements by questionnaire at baseline and after 4 weeks.
Tidsramme: Baseline and after 4 weeks.
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Baseline and after 4 weeks.
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Change in stool consistency (Bristol Stool Scale) at baseline and after 4 weeks.
Tidsramme: Baseline and after 4 weeks.
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Baseline and after 4 weeks.
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Change in Whole Gut Transit Time (radio-opaque markers) at baseline and during the 4th week.
Tidsramme: Baseline and during the 4th week.
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Baseline and during the 4th week.
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Change in fecal bulk (stool weight) at baseline and after 4 weeks.
Tidsramme: Baseline and after 4 weeks.
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Baseline and after 4 weeks.
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Change in constipation symptoms assessed by questionnaire at baseline and after 2 and 4 weeks.
Tidsramme: Baseline and after 2 and 4 weeks. Validated questionnaire.
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Baseline and after 2 and 4 weeks. Validated questionnaire.
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Evolution of Health related Quality of Life assessed by questionnaire at baseline and after 2 and 4 weeks.
Tidsramme: Baseline and after 2 and 4 weeks. Validated questionnaire.
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Baseline and after 2 and 4 weeks. Validated questionnaire.
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Study product satisfaction by questionnaire after 2 and 4 weeks.
Tidsramme: after 2 and 4 weeks.
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after 2 and 4 weeks.
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Adverse events in the week before baseline, at baseline, week 3, 4 and 5.
Tidsramme: Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)
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Evaluation of safety will be assessed with AE and SAE reporting throughout the whole study i.e. day -7 (screening period), day 0 (randomisation), day 15, day 22 and day 29 (end of study)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2015
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
12. oktober 2016
Datoer for studieregistrering
Først indsendt
24. april 2015
Først indsendt, der opfyldte QC-kriterier
2. juni 2015
Først opslået (Skøn)
3. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NU373
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .