NCT03550742

Brief Summary

This is an open labeled, one-armed real-world study in IBS-patients. All participants will receive active treatment for 12 weeks. The primary objective of the study is to assess the effect of Human Milk Oligosaccharides (HMOs) on bowel function in adults with IBS. Secondary objectives are to evaluate HMOs' tolerability, effect on participant reported satisfaction with bowel habits, interference with life in general, quality of life, somatic symptoms, and anxiety and depression in all patients and subgroups of patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

May 9, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 8, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

May 9, 2018

Last Update Submit

April 24, 2019

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Human Milk OligosaccharidesIBS-CIBS-DIBS-M

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in bowel function

    Change from baseline in bowel function assessed as the proportion of bowel movements with abnormal fecal consistency measured with the Bristol Stool Form Scale

    Baseline and after 4, 8 and 12 weeks of intake

Secondary Outcomes (8)

  • Change in patients' perception of body function

    Baseline and after 4, 8 and 12 weeks of intake

  • Evaluate tolerability of fuco-N-tetraose

    Baseline and after 4, 8 and 12 weeks of intake

  • Evaluate tolerability of fuco-N-tetraose

    Baseline and after 4, 8 and 12 weeks of intake

  • Change in satisfaction with bowel habits

    Baseline and after 4, 8 and 12 weeks of intake

  • Change in IBS' interference in life in general

    Baseline and after 4, 8 and 12 weeks of intake

  • +3 more secondary outcomes

Study Arms (1)

Intervention

EXPERIMENTAL

Daily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks.

Other: Fuco-N-Tetraose

Interventions

Fuco-N-TetraoseOTHER

Daily bolus of Fuco-N-Tetraose

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to give oral and written informed consent
  • Age minimum 18 years at enrolment
  • Current clinical diagnosis of IBS from a healthcare provider, and meeting Rome IV IBS diagnostic criteria
  • Ability and willingness to understand and comply with the study procedures
  • Ability to read, speak and understand English
  • Free access to the internet via computer, tablet or smartphone to complete study surveys and also to allow for study team follow-up as needed.

You may not qualify if:

  • Participation in a clinical intervention study one month prior to screening visit and throughout the study.
  • Medically diagnosed with celiac disease, Crohn's disease, ulcerative colitis, diverticulitis, inflammatory bowel disease, or clostridium difficile infection by a doctor
  • Pregnant or lactating or wish to become pregnant during the period of the study.
  • Lack of suitability for participation in the study for any reason as judged by the site investigator or Principal Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (1)

  • Palsson OS, Peery A, Seitzberg D, Amundsen ID, McConnell B, Simren M. Human Milk Oligosaccharides Support Normal Bowel Function and Improve Symptoms of Irritable Bowel Syndrome: A Multicenter, Open-Label Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00276. doi: 10.14309/ctg.0000000000000276.

    PMID: 33512807DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Olafur Palsson, PsyD, Prof

    UNC-Chapel Hill School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 8, 2018

Study Start

May 14, 2018

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)