Is Microbiota Community Associated With Clinical Response... | NCT02565550

Studies
Is Microbiota Community Associated With Clinical Response to a Low FODMAP Diet in Patients With Irritable Bowel Syndrome

NCT02565550

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Oct 1, 2015Estimated

Enrollment

90Estimated

Phase

Phase 4

Conditions

Irritable Bowel Syndrome

Interventions

low FODMAPs

Countries

China

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

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Nov 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Sep 30, 2015

First Posted Date

Oct 1, 2015Estimated

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

Sep 30, 2015

Last Update Posted Date

Oct 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To determine the efficacy of a low FODMAP diet in IBS patients and whether gut microbiota community is associated with its efficacy.

Detailed Description

We seek to determine whether a low FODMAPs diet decreases symptoms in irritable bowel syndrome (IBS)patients and to identify potential microbial factors related to diet efficacy. Pain symptoms, stooling characteristics, breath hydrogen, stool microbiome will be collected and/or documented in IBS patients at baseline and during one week of an low FODMAPs intervention.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IBS patients	Experimental	eat the low FODMAPs diet for one week	Dietary Supplement: low FODMAPs
healthy controls	Active Comparator	eat the low FODMAPs diet for one week	Dietary Supplement: low FODMAPs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low FODMAPs	Dietary Supplement	low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols	IBS patients healthy controls

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes of symptom scores		5 months

Secondary Outcomes

Measure	Description	Time Frame
proportion of responders		3 months
quality of life in IBS patients		5 months
microbial composition in different response to low FODMAPs

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the presence of Rome III criteria for IBS ;
Patients scheduled for colonoscopy examination or having negative screening examinations
Aged between 18 and 65 years old

Exclusion Criteria:

Antibiotic, probiotic or laxative usage within 4 weeks.
organic gastrointestinal diseases
Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
pregnancy or lactation.
previous major or complicated abdominal surgery.
severe endometriosis and dementia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing Li, MD.PhD	Contact	86-531-82169236	86-531-8216923	liyanqing@sdu.edu.cn

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD.PhD	Qilu Hospital of Shandong University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong	250012	China

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000092622	FODMAP Diet

Ancestor Terms

ID	Term
D000092724	Elimination Diets
D004032	Diet
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition

Browse Leaves

Not provided

Browse Branches

Not provided