Lactose IntoleranceNCT01286597
The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
A study testing dietary restriction in people with Lactose Intolerance and Irritable Bowel Syndrome, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance, Irritable Bowel Syndrome
- What is being tested?
- dietary restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital , College of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310016
Ning Dai, MD, 0086-13867457664, dainingcn@gmail.com
About this study
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.
Read the 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
- Conditions
- Lactose Intolerance, Irritable Bowel Syndrome
- Being tested
- dietary restriction
- Keywords
- lactose intolerance, DNA sequencing, psychosocial factors, irritable bowel syndrome, visceral hypersensitivity
- Medical subject headings
- Lactose Intolerance, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary restrictionDietary supplement
Also called exclusion diet；food restriction；dietary treatment
restrict intake of lactose
| Study group | Role | What they receive |
|---|---|---|
| dietary | Experimental | Not described Receives: Dietary Supplement: dietary restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effects of lactose intolerance on gastrointestinal function and symptoms
Measured: Three years
Secondary outcomes (5)
To measure the intake of dietary lactose in the adult general population and in patients with IBS
Measured: three years
To assess genetic factors, tolerance to lactose challenge and visceral sensitivity.
Measured: three years
To assess appropriate dosage of lactose hydrogen breath test
Measured: two years
To determine the impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.
Measured: three years
To explore the association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Principal investigator, DAI Ning, Sir Run Run Shaw Hospital
- Investigators
- Ning DAI, MD, Study chair, Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286597
- Sponsor's protocol ID
- 120100047
- Status last verified
- Jul 2012
- First submitted
- 18 Jan 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen B, Du L, Zhang Y, Cen M, Luo L, Xu M, Kim JJ, Dai N. Natural History and Outcomes of Individuals With Functional Bowel Disorder: A 9-year Population-Based Longitudinal Study. Clin Transl Gastroenterol. 2024 Jul 1;15(7):e00715. doi: 10.14309/ctg.0000000000000715.
PubMed 38752653Yang JF, Fox M, Chu H, Zheng X, Long YQ, Pohl D, Fried M, Dai N. Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea. World J Gastroenterol. 2015 Jun 28;21(24):7563-70. doi: 10.3748/wjg.v21.i24.7563.
PubMed 26140004Yang J, Fox M, Cong Y, Chu H, Zheng X, Long Y, Fried M, Dai N. Lactose intolerance in irritable bowel syndrome patients with diarrhoea: the roles of anxiety, activation of the innate mucosal immune system and visceral sensitivity. Aliment Pharmacol Ther. 2014 Feb;39(3):302-11. doi: 10.1111/apt.12582. Epub 2013 Dec 5.
PubMed 24308871Yang 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.
PubMed 23246646
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population
- ClinicalTrials.gov ID
- NCT01286597
- Acronym / sponsor ID
- 120100047
- Conditions
- Lactose Intolerance, Irritable Bowel Syndrome
- Keywords
- lactose intolerance, DNA sequencing, psychosocial factors, irritable bowel syndrome, visceral hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dietary | Experimental | Dietary Supplement: dietary restriction |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary restrictionAlso: exclusion diet；food restriction；dietary treatmentrestrict intake of lactose | Dietary supplement | dietary |
Primary outcome
To assess the effects of lactose intolerance on gastrointestinal function and symptoms
Time frame: Three years
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Derived from this study: PubMed 38752653Chen B, Du L, Zhang Y, Cen M, Luo L, Xu M, Kim JJ, Dai N. Natural History and Outcomes of Individuals With Functional Bowel Disorder: A 9-year Population-Based Longitudinal Study. Clin Transl Gastroenterol. 2024 Jul 1;15(7):e00715. doi: 10.14309/ctg.0000000000000715.
- Derived from this study: PubMed 26140004Yang JF, Fox M, Chu H, Zheng X, Long YQ, Pohl D, Fried M, Dai N. Four-sample lactose hydrogen breath test for diagnosis of lactose malabsorption in irritable bowel syndrome patients with diarrhea. World J Gastroenterol. 2015 Jun 28;21(24):7563-70. doi: 10.3748/wjg.v21.i24.7563.
- Derived from this study: PubMed 24308871Yang J, Fox M, Cong Y, Chu H, Zheng X, Long Y, Fried M, Dai N. Lactose intolerance in irritable bowel syndrome patients with diarrhoea: the roles of anxiety, activation of the innate mucosal immune system and visceral sensitivity. Aliment Pharmacol Ther. 2014 Feb;39(3):302-11. doi: 10.1111/apt.12582. Epub 2013 Dec 5.
- Derived from this study: PubMed 23246646Yang 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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Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning DAI, MD study chair
Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary restriction in people with Lactose Intolerance and Irritable Bowel Syndrome, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ning DAI, MD (0086-13867457664, dainingcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effects of lactose intolerance on gastrointestinal function and symptoms (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01286597, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.