The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
Recruitment status was: Recruiting
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.
|Lactose Intolerance Irritable Bowel Syndrome||Dietary Supplement: dietary restriction|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
|Official Title:||The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population|
- To assess the effects of lactose intolerance on gastrointestinal function and symptoms [ Time Frame: Three years ]
- To measure the intake of dietary lactose in the adult general population and in patients with IBS [ Time Frame: three years ]
- To assess genetic factors, tolerance to lactose challenge and visceral sensitivity. [ Time Frame: three years ]
- To assess appropriate dosage of lactose hydrogen breath test [ Time Frame: two years ]
- To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS. [ Time Frame: three years ]
- To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients [ Time Frame: two years ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Dietary Supplement: dietary restriction
restrict intake of lactose
Other Name: exclusion diet；food restriction；dietary treatment
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286597
|Contact: Ning DAI, MDfirstname.lastname@example.org|
|Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China||Recruiting|
|Hangzhou, Zhejiang, China, 310016|
|Contact: Ning Dai, MD 0086-13867457664 email@example.com|
|Study Chair:||Ning DAI, MD||Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China|