The Effects of Lactose Intolerance on Gastrointestinal Fu... | NCT01286597

Studies
The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population

NCT01286597

Sponsor

Sir Run Run Shaw Hospital

Status

Unknown status

Last Update Posted

Jul 10, 2012Estimated

Enrollment

3,000Estimated

Phase

Not Applicable

Conditions

Lactose Intolerance
Irritable Bowel Syndrome

Interventions

dietary restriction

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

Jul 2012

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

Jan 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jan 18, 2011

First Submission Date that Met QC Criteria

Jan 27, 2011

First Posted Date

Jan 31, 2011Estimated

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

Jul 7, 2012

Last Update Posted Date

Jul 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

DAI Ning, Director of Gastroenterology department, Sir Run Run Shaw HospitalPrincipal Investigator

Lead Sponsor

Sir Run Run Shaw HospitalOTHER

Collaborators

Name	Class
University Hospital, Zürich	OTHER

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

Lactose is a carbohydrate found in milk,and Lactase Deficiency (LD) is a condition in which the small intestine cannot digest this carbohydrate due to absent or insufficient amounts of lactase.Individuals with LD may be intolerant of lactose in the diet and experience abdominal cramps, bloating and diarrhea; however the response is variable.Some tolerate moderate amounts of lactose without adverse effect,whereas others experience severe symptoms in response to even small doses. These problems may be representative of wider issues regarding individual tolerance to diet containing ubiquitous poorly absorbed, fermentable carbohydrates (such as: fructose, fructans)and be relevant to symptom generated in patients with diarrhea predominant irritable bowel syndrome (D-IBS).

This project will investigate the effects of diet,lifestyle stress and psychiatric dietary on the development of functional gastrointestinal symptoms. Lactose will be used to assess tolerance to dietary challenge, a test that is particularly relevant in a Chinese population with a high prevalence of lactase deficiency.

Detailed Description

Study #1: Questionnaire study in general Chinese population (n=2000).

Study #2: Physiologic study in patients attending gastroenterology clinic (n=600) including in subgroups assessment of genetic factors,tolerance to lactose challenge and assessment of visceral sensitivity.

Study #3: Assessment of appropriate dosage of lactose hydrogen breath test in a population with high-prevalence of lactase deficiency.

Study #4: Impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.

study #5: The association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS 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

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
dietary	Experimental		Dietary Supplement: dietary restriction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dietary restriction	Dietary Supplement	restrict intake of lactose	dietary

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the effects of lactose intolerance on gastrointestinal function and symptoms		Three years

Secondary Outcomes

Measure	Description	Time Frame
To measure the intake of dietary lactose in the adult general population and in patients with IBS		three years
To assess genetic factors, tolerance to lactose challenge and visceral sensitivity.		three years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged at least 16 years old and not more than 75 years old.
Ability to communicate with the investigator, complete study questionnaires (with help of investigator) and provide informed consent.

Exclusion Criteria:

Progressive, severe disease requiring active medical management (e.g. advanced cardiac, liver, renal or neurological disease, advanced cancer)
History of significant gastrointestinal pathology (other than gastro-oesophageal reflux disease and functional bowel diseases)
History of gastro-intestinal surgery (except appendicectomy, cholecystectomy, hernia repair).
Evidence of active drug or alcohol abuse

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ning DAI, MD	Contact	0086-13867457664		dainingcn@gmail.com

Overall Officials

Name	Affiliation	Role
Ning DAI, MD	Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China	Recruiting	Hangzhou	Zhejiang	310016	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38752653	Derived	Chen B, Du L, Zhang Y, Cen M, Luo L, Xu M, Kim JJ, Dai N. Natural History and Outcomes of Individuals With Functional Bowel Disorder: A 9-year Population-Based Longitudinal Study. Clin Transl Gastroenterol. 2024 Jul 1;15(7):e00715. doi: 10.14309/ctg.0000000000000715.
26140004	Derived	Yang JF, Fox M, Chu H, Zheng X, Long YQ, Pohl D, Fried M, Dai N. Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea. World J Gastroenterol. 2015 Jun 28;21(24):7563-70. doi: 10.3748/wjg.v21.i24.7563.

ID	Term
D008286	Malabsorption Syndromes
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics

ID	Term
D007787	Lactose Intolerance
D043183	Irritable Bowel Syndrome