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

Primary Purpose

Functional Gastrointestinal Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inulin
Maltodextrine
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring intestinal gas, functional gut symptoms, intestinal sensitivity, intestinal motility

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Inulin 8 g/d

    maltodextrine 8 g/d

    Arm Description

    Mixture of oligo- and polysaccharides composed of fructose units connected by β (2→1) links with a total number of fructose and glucose units ranging between 2 and 70.

    Outcomes

    Primary Outcome Measures

    Perception of intestinal gas infusion
    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 Outcome Measures

    Intestinal gas retention
    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.
    Digestive well-being
    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.
    Abdominal discomfort
    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.
    Bowel habit
    Effect of inulin intake (change from baseline with inulin versus placebo) on the number of bowel movements measured by daily questionnaires during 6 days.

    Full Information

    First Posted
    March 18, 2016
    Last Updated
    March 29, 2016
    Sponsor
    Hospital Universitari Vall d'Hebron Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02727166
    Brief Title
    Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function
    Official Title
    Efecto de Fructanos Paralelamente Hidrolizados Provenientes de Achicoria Sobre Las Sensaciones Abdominales
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    July 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital Universitari Vall d'Hebron Research Institute

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Gastrointestinal Disorders
    Keywords
    intestinal gas, functional gut symptoms, intestinal sensitivity, intestinal motility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inulin 8 g/d
    Arm Type
    Experimental
    Arm Description
    Mixture of oligo- and polysaccharides composed of fructose units connected by β (2→1) links with a total number of fructose and glucose units ranging between 2 and 70.
    Arm Title
    maltodextrine 8 g/d
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Inulin
    Intervention Description
    Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Maltodextrine
    Intervention Description
    Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
    Primary Outcome Measure Information:
    Title
    Perception of intestinal gas infusion
    Description
    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.
    Time Frame
    60 last min of the 180 min gas infusion test
    Secondary Outcome Measure Information:
    Title
    Intestinal gas retention
    Description
    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.
    Time Frame
    60 last min of the 180 min gas infusion test
    Title
    Digestive well-being
    Description
    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.
    Time Frame
    6 last days of intervention
    Title
    Abdominal discomfort
    Description
    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.
    Time Frame
    6 last days of intervention
    Title
    Bowel habit
    Description
    Effect of inulin intake (change from baseline with inulin versus placebo) on the number of bowel movements measured by daily questionnaires during 6 days.
    Time Frame
    6 last days of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fernando Azpiroz, MD
    Organizational Affiliation
    Vall d'Hebron Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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