The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
| Tracking Information | |||||
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| First Received Date ICMJE | January 18, 2011 | ||||
| Last Updated Date | July 7, 2012 | ||||
| Start Date ICMJE | January 2011 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To assess the effects of lactose intolerance on gastrointestinal function and symptoms [ Time Frame: Three years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
To assess the effects of lactose intolerance on gastrointestinal function and symptoms [ Time Frame: From September 2008 to December 2011 ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT01286597 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population | ||||
| Official Title ICMJE | The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population | ||||
| 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. |
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| 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 |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
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| Condition ICMJE |
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| Intervention ICMJE | Dietary Supplement: dietary restriction
restrict intake of lactose
Other Name: exclusion diet;food restriction;dietary treatment |
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| Study Arm (s) | Experimental: dietary
Intervention: Dietary Supplement: dietary restriction |
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| Publications * | Yang J, Deng Y, Chu H, Cong Y, Zhao J, Pohl D, Misselwitz B, Fried M, Dai N, Fox M. Prevalence and presentation of lactose intolerance and effects on dairy product intake in healthy subjects and patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Mar;11(3):262-268.e1. doi: 10.1016/j.cgh.2012.11.034. Epub 2012 Dec 13. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01286597 | ||||
| Other Study ID Numbers ICMJE | 120100047 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | DAI Ning, Sir Run Run Shaw Hospital | ||||
| Study Sponsor ICMJE | Sir Run Run Shaw Hospital | ||||
| Collaborators ICMJE | University Hospital, Zürich | ||||
| Investigators ICMJE |
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| Information Provided By | Sir Run Run Shaw Hospital | ||||
| Verification Date | July 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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