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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01286597
• Other study ID #: 120100047
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2011
• Last updated: July 7, 2012
• Start date: January 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2012
• Source: Sir Run Run Shaw Hospital
• Contact: Ning DAI, MD
• Phone: 0086-13867457664
• Email: dainingcn[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Lactose Intolerance

Intervention

Dietary Supplement:
• dietary restriction
restrict intake of lactose

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital	University Hospital, Zürich

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effects of lactose intolerance on gastrointestinal function and symptoms		Three years	No
Secondary	To measure the intake of dietary lactose in the adult general population and in patients with IBS		three years	No
Secondary	To assess genetic factors, tolerance to lactose challenge and visceral sensitivity.		three years	No
Secondary	To assess appropriate dosage of lactose hydrogen breath test		two years	No
Secondary	To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.		three years	No
Secondary	To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients		two years	No