The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lactose Intolerance Irritable Bowel Syndrome |
Dietary Supplement: dietary restriction |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
- To measure the intake of dietary lactose in the adult general population and in patients with IBS [ Time Frame: three years ] [ Designated as safety issue: No ]
- To assess genetic factors, tolerance to lactose challenge and visceral sensitivity. [ Time Frame: three years ] [ Designated as safety issue: No ]
- To assess appropriate dosage of lactose hydrogen breath test [ Time Frame: two years ] [ Designated as safety issue: No ]
- To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS. [ Time Frame: three years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 3000 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: dietary |
Dietary Supplement: dietary restriction
restrict intake of lactose
Other Name: exclusion diet；food restriction；dietary treatment
|
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
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Ning DAI, MD | 0086-13867457664 | dainingcn@gmail.com |
| China, Zhejiang | |
| Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China | Recruiting |
| Hangzhou, Zhejiang, China, 310016 | |
| Contact: Ning Dai, MD 0086-13867457664 dainingcn@gmail.com | |
| Study Chair: | Ning DAI, MD | Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China |
More Information
No publications provided by Sir Run Run Shaw Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | DAI Ning, Director of Gastroenterology department, Sir Run Run Shaw Hospital |
| ClinicalTrials.gov Identifier: | NCT01286597 History of Changes |
| Other Study ID Numbers: | 120100047 |
| Study First Received: | January 18, 2011 |
| Last Updated: | July 7, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Sir Run Run Shaw Hospital:
|
lactose intolerance DNA sequencing psychosocial factors irritable bowel syndrome visceral hypersensitivity |
Additional relevant MeSH terms:
|
Irritable Bowel Syndrome Lactose Intolerance Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases |
Digestive System Diseases Malabsorption Syndromes Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013