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Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function

NCT02727166 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2016-04-04

No results posted yet for this study

Summary

Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods. Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms and gas retention for 3 h) will be performed before and at the end of the intervention phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal bifidobacteria counts will be measured before and at the end of the intervention.

Conditions

  • Functional Gastrointestinal Disorders

Interventions

DIETARY_SUPPLEMENT

Inulin

Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

DIETARY_SUPPLEMENT

Maltodextrine

Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Fernando Azpiroz, MD · Vall d'Hebron Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-07-31
Completion
2015-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02727166 on ClinicalTrials.gov