NCT02548247

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
Last Updated

September 14, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

September 4, 2015

Last Update Submit

September 11, 2015

Conditions

HealthyConstipation

Keywords

Stool frequencyBowel motor functionOrafti® InulinDietary Fiber

Outcome Measures

Primary Outcomes (1)

  • Stool frequency determined by daily questionnaire

    Stool frequency determined by daily questionnaire.

    4 weeks

Secondary Outcomes (5)

  • Stool consistency rated according to the Bristol Stool Form Scale

    4 weeks

  • Questionnaire on Gastrointestinal characteristics

    4 weeks

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

    4 weeks

  • Faecal microbiota composition determined by illumina sequencing

    4 weeks

  • Stool metabolite profiling determined by GC/LC-MS

    4 weeks

Study Arms (2)

Orafti® Inulin

EXPERIMENTAL

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

Dietary Supplement: Orafti® Inulin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Orafti® InulinDIETARY_SUPPLEMENT

Dietary fiber

Orafti® Inulin
PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Related Publications (2)

  • Vandeputte D, Falony G, Vieira-Silva S, Wang J, Sailer M, Theis S, Verbeke K, Raes J. Prebiotic inulin-type fructans induce specific changes in the human gut microbiota. Gut. 2017 Nov;66(11):1968-1974. doi: 10.1136/gutjnl-2016-313271. Epub 2017 Feb 17.

    PMID: 28213610DERIVED

  • Micka A, Siepelmeyer A, Holz A, Theis S, Schon C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017 Feb;68(1):82-89. doi: 10.1080/09637486.2016.1212819. Epub 2016 Aug 5.

    PMID: 27492975DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Menzel, MD

    BioTeSys GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2015

First Posted

September 14, 2015

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

September 14, 2015

Record last verified: 2015-09

Locations

DE(1)