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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01286597
Enrollment
3000
Registered
2011-01-31
Start date
2011-01-31
Completion date
2012-12-31
Last updated
2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome, Lactose Intolerance

Keywords

lactose intolerance, DNA sequencing, psychosocial factors, irritable bowel syndrome, visceral hypersensitivity

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.

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

Interventions

DIETARY_SUPPLEMENTdietary restriction

restrict intake of lactose

Sponsors

University Hospital, Zürich
CollaboratorOTHER
Sir Run Run Shaw Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
To assess the effects of lactose intolerance on gastrointestinal function and symptomsThree years

Secondary

MeasureTime frame
To measure the intake of dietary lactose in the adult general population and in patients with IBSthree years
To assess genetic factors, tolerance to lactose challenge and visceral sensitivity.three years
To assess appropriate dosage of lactose hydrogen breath testtwo years
To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.three years
To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patientstwo years

Countries

China

Contacts

Primary ContactNing DAI, MD
dainingcn@gmail.com0086-13867457664

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026