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Completed

NCT Number: NCT02548247

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

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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Key information

Conditions

Healthy Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Orafti® Inulin

Dietary Supplement

Dietary fiber

Placebo

Dietary Supplement

Maltodextrin

Primary outcomes

  1. Stool frequency determined by daily questionnaire

    Time frame: 4 weeks

    Stool frequency determined by daily questionnaire.

Secondary outcomes

  1. Stool consistency rated according to the Bristol Stool Form Scale

    Time frame: 4 weeks

    Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7.

  2. Questionnaire on Gastrointestinal characteristics

    Time frame: 4 weeks

    Sensation of straining, abdominal discomfort, bloating/distension, passage of gas and feeling of incomplete emptying rated on a 5-point scale (0 = not at all, 1 = very slightly, 2 = slightly, 3 = moderately, 4 = extremely).

  3. Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)

    Time frame: 4 weeks

    Severity of each symptom rated on a five-point scale from 0 (not at all / none of the time) to 4 (extremely / all of the time).

  4. Faecal microbiota composition determined by illumina sequencing

    Time frame: 4 weeks

    Determined by illumina sequencing.

  5. Stool metabolite profiling determined by GC/LC-MS

    Time frame: 4 weeks

    Determined by GC/LC-MS.

Sponsors and collaborators

Lead sponsor

Beneo GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2015
Registry last updated
Sep 14, 2015

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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