Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.

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Detailed Description

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Conditions

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Healthy Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Orafti® Inulin

Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks

Group Type EXPERIMENTAL

Orafti® Inulin

Intervention Type DIETARY_SUPPLEMENT

Dietary fiber

Placebo

Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Interventions

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Orafti® Inulin

Dietary fiber

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
* Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months.
* Age ≥ 20 and ≤ 75

Exclusion Criteria

* Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries.
* Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial.
* Subjects with stool frequency of \<1 stool every 7 days or more than 3 stools per week.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes