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Completed

NCT Number: NCT02727166

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

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.

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • negative sensation of digestive well-being (score ≤ 1 on at least 2 of the 6 evaluation days, scored on a - 5 / +5 scale.
  • poor tolerance of a gas challenge test (abdominal perception score ≥ 3, on a 0-6 scale, for at least three 15-min time points over the last 90 minutes of the 180-minute-long intestinal gas infusion test).

Exclusion criteria

  • antibiotic intake,
  • exceptional diets,
  • changes in dietary habits or intake of Ca supplements over the preceding month.

Treatment and study plan

Inulin

Dietary Supplement

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

Maltodextrine

Dietary Supplement

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

Primary outcomes

  1. Perception of intestinal gas infusion

    Time frame: 60 last min of the 180 min gas infusion test

    Effect of inulin intake (change from baseline with inulin versus placebo) on the tolerance of the gas challenge test, measured as the perception score of digestive sensations during the gas challenge test. At each time point, the highest score instead of the mean or cumulative scores will be computed for comparisons; these scores will be averaged over the last 60 min of the test in each subject; the differences between basal and intervention periods (inulin or placebo) will be calculated.

Secondary outcomes

  1. Intestinal gas retention

    Time frame: 60 last min of the 180 min gas infusion test

    Effect of inulin intake (change from baseline with inulin versus placebo) on the volume of gas retention (volume infused minus volume evacuated) measured as the average value over the last 60 min of the gas infusion test.

  2. Digestive well-being

    Time frame: 6 last days of intervention

    Effect of inulin intake (change from baseline with inulin versus placebo) on digestive well-being measured by daily questionnaires on - 5 to + 5 score scales and averaged over 6 days.

  3. Abdominal discomfort

    Time frame: 6 last days of intervention

    Effect of inulin intake (change from baseline with inulin versus placebo) on abdominal discomfort measured by daily questionnaires on 0 to 10 score scales and averaged over 6 days.

  4. Bowel habit

    Time frame: 6 last days of intervention

    Effect of inulin intake (change from baseline with inulin versus placebo) on the number of bowel movements measured by daily questionnaires during 6 days.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Efecto de Fructanos Paralelamente Hidrolizados Provenientes de Achicoria Sobre Las Sensaciones Abdominales

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2016
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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