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

Not Applicable

• Conditions: Lactose Intolerance; Irritable Bowel Syndrome
• Interventions: Dietary Supplement: dietary restriction

• Registration Number: NCT01286597
• Lead Sponsor: Sir Run Run Shaw Hospital

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-27
• Study First Posted: 2011-01-31
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-07
• Last Update Posted: 2012-07-10
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary	dietary restriction	-

Primary Outcome Measures

Name	Time	Method
To assess the effects of lactose intolerance on gastrointestinal function and symptoms	Three years

Secondary Outcome Measures

Name	Time	Method
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
To assess appropriate dosage of lactose hydrogen breath test	two years
To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.	three years
To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients	two years

Trial Locations

Locations (1)

Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China; 🇨🇳 Hangzhou, Zhejiang, China