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

Zhejiang University

Status: Unknown

Conditions: Irritable Bowel Syndrome; Lactose Intolerance

Treatments: Dietary Supplement: dietary restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT01286597

120100047

Details and patient eligibility

About

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.

Full 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

Enrollment: 3,000 estimated patients

Sex: All

Ages: 16 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

dietary

Experimental group

Treatment:

Dietary Supplement: dietary restriction