An interventional study of dietary restriction in Lactose Intolerance and Irritable Bowel Syndrome, sponsored by Sir Run Run Shaw Hospital. Status unknown at 1 site in China. Open to participants aged 16 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-10.
Sponsored by Sir Run Run Shaw Hospital · Not applicable and Interventional
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.
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
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: dietary restriction
restrict intake of lactose
Also known as: exclusion diet；food restriction；dietary treatment
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
The record gives a start of Jan 2011, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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