Effect of HMOs as Nutritional Support for Normal Bowel Mo... | NCT03550742

Studies
Effect of HMOs as Nutritional Support for Normal Bowel Movements in IBS Patients

NCT03550742

Sponsor

Glycom, Inc.

Status

Completed

Last Update Posted

Apr 25, 2019Actual

Enrollment

317Actual

Phase

Not Applicable

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

Fuco-N-Tetraose

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CT-2017-01	Other Identifier	IntegReview IRB

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2018Actual

Primary Completion Date

Mar 20, 2019Actual

Completion Date

Mar 20, 2019Actual

First Submitted Date

May 9, 2018

First Submission Date that Met QC Criteria

Jun 7, 2018

First Posted Date

Jun 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2019

Last Update Posted Date

Apr 25, 2019Actual

Name	Class
University of North Carolina	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In this trial, a total of 300 adults (at least 18 years of age) diagnosed with irritable bowel syndrome (IBS) in accordance with the Rome IV criteria will be included. Patients will be recruited from gastroenterologists and primary care clinics across the USA. The study product, Fuco-N-Tetraose, will be taken daily throughout the course of the trial. All data will be collected through 4 web based surveys, and the participants will complete those at baseline before the intervention starts, and after 4, 8 and 12 weeks of intake of the study product.

The primary outcome of the study will be assessed by the Patients' Global Impression of Change (PGIC) scale. Other questionnaires used in the study includes the IBS specific Gastrointestinal Symptom Rating Scale (GSRS-IBS), the IBS Quality of Life Scale (IBS-QoL), the Participant Health Questionnaire-4 (PHQ-4), the Participant Health Questionnaire-12 (PHQ-12), and the Bristol Stool Form Scale (BSFS). All outcomes will be evaluated in all patients and in sub-groups of patients. i.e. subtypes by predominant bowel habit (diarrhea-predominant, constipation-predominant, or altered/mixed pattern), and lactose intolerant patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

317Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Daily administration of 5g of Fuco-N-Tetraose as a bolus for a period of 12 weeks.	Other: Fuco-N-Tetraose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fuco-N-Tetraose	Other	Daily bolus of Fuco-N-Tetraose	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in patients' perception of body function	Change from baseline in patients' perception of body function measured by the Patients' Global Impression of Change (PGIC) scale.	Baseline and after 4, 8 and 12 weeks of intake
Evaluate tolerability of fuco-N-tetraose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olafur Palsson, PsyD, Prof	UNC-Chapel Hill School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Carolina		Chapel Hill	North Carolina	27516	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33512807	Derived	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.

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases