Lactose IntoleranceNCT03860051
Association Between Lactase Deficiency, and the Small Intestinal Microbiome in Adults.
An observational study of Lactose Intolerance, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2018to 30 Jun 2023
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient ages 18-75 presenting for upper gastrointestinal endoscopy for any indication except those outlined in the exclusion criteria below at the IU GI Endoscopy Sites including: IU North Hospital, Glen Lehman Endoscopy Suite, Springmill/Beltway Surgery Center, IU Saxony, and Eskenazi Hospital will be eligible for participation. Participants should be willing and able to sign informed consent.
Who may be able to join
None listed.
Who cannot join
- Patients with known bleeding diathesis given the need for small intestinal mucosal biopsies.
- Patients with known history of eosinophilic esophagitis, inflammatory bowel disease, chronic pancreatitis or pancreatic insufficiency, celiac disease, peptic duodenitis
- Antibiotic-use within the last 30 days
- Major abdominal surgery except appendectomy or cholecystectomy > 6 months prior to enrollment
- Prior radiation therapy of the abdomen
- Use of tobacco products within the last 3 months
Show all 17Show fewer
- Allergy to milk
- Currently pregnant or breast-feeding
- Patients taking anti-coagulant drugs
- Meeting any of the exclusion criteria as listed for Aim 1
- Known diagnosis of disorders associated with abnormal GI motility (gastroparesis, amyloidosis, neuromuscular disease including Parkinson's disease, collagen vascular disease, chronic malnutrition, and uncontrolled thyroid disease)
- History of small intestinal bacterial overgrowth
- Active peptic ulcer disease noted at the time of endoscopy
- Recent colonoscopy bowel preparation or colonic enema in the preceding 4 weeks
- Chronic immunodeficiency or chronic infectious illness
- Currently undergoing chemotherapy
- Patients taking anti-coagulant drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Association Between Lactase Deficiency, Symptoms of Lactose Intolerance, and the Small Intestinal Microbiome in Adults
The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance.
Read the detailed description
The study involves 3 visits and will include 2 types of subjects - those who have the the diagnosis of lactose intolerance (subjects) and those who do not have lactose intolerance (controls).
Visit 1:
In total, it is estimated that the research participation will add about 1 hour to your planned procedure visit. At Visit 1 following will be done
- Subjects will be asked to read and sign the informed consent after all the questions about the study have been answered.
- General medical history will be taken including demographics, symptoms and history of illness, and medication review.
- Vital signs (blood pressure, temperature, respiration, height, and weight) will be recorded.
- Subjects will be asked to complete 2 questionnaires
- Upper endoscopy will be done as part of routine clinical care
- At the time of the endoscopy 4 extra biopsies (small piece of tissue) from the small intestines will be taken. The biopsies will be used for research to detect the bacteria and to measure the lactase enzyme.
- Small sample of blood (10 mL) (2 teaspoons) will be taken for storage for possible future testing. This will be a one time draw only.
- The research team may contact the subjects to arrange a Visit 2 if they are interested in proceeding with the next step in this research study.
Visit 2:
Visit 2 will take approximately 6 hours to complete. If the subject returns for Visit 2, they will do the following
- They will return to the research office at Indiana University to participate in hydrogen breath test (test that uses the measurement of hydrogen in the breath to diagnose several conditions) to see how the body reacts to lactose. This involves drinking milk, then blowing into a bag so we can collect breath samples. Subjects will be asked to report any symptoms they might have during this time. This test will take approximately 6 hours. They will be instructed to eat a low-fiber meal the night before the test, and asked to fast for the 12 hours before the test. They can drink water during this time.
- They will be also be asked to provide a stool sample for future analysis. Instructions for collection, storage and transportation of stool will be provided. They will be provided a kit for stool collection, storage and transportation. They will be asked to collect stool at home over the course of 2 days and store as per instructions. Stool will need to be refrigerated and brought back to the office on ice.
Visit 3:
Visit 3 will take approximately less than one hour to complete. For those who are interested in returning for Visit 3,
- Subjects will be asked to return to the clinic with the stool samples.
- They will complete the study at this time.
Participants who complete Aim 1 and meet further eligibility criteria for Aim 2 may be contacted by research staff to return for Visit 2 (breath test). Those who are agreeable to participating and are scheduled for Visit 2 will be instructed to consume a low-fiber meal and fast for 12 hours prior to their breath test. We will contact the participant 24 to 48 hours prior to the test day as a reminder to consume a low fiber meal and fast for 12 hours.
- Conditions
- Lactose Intolerance
- Medical subject headings
- Lactose Intolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactase activity
Lactase activity (µmol/min/g) will be assessed from small bowel biopsy specimens
Measured: 1 day
Secondary outcomes (4)
Symptom severity
We will assess symptom severity using the lactose assessment tool
Measured: 1 day
Small intestinal mucosal microbiome
The small intestinal microbiome will be assessed by 16S allele PCR sequencing (16S) and Shotgun Metagenomic Sequencing (SGS)
Measured: 1 day
Maldigestion status
Maldigestion status will be assessed by hydrogen breath test
Measured: 1 day
Fecal microbiome
The fecal microbiome will be assessed by 16S allele PCR sequencing (16S) and Shotgun Metagenomic Sequencing (SGS)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start21 Nov 2018
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose IntoleranceStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huiping Xu, Indiana University
- Investigators
- Andrea S Shin, MD, Principal investigator, IU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860051
- Sponsor's protocol ID
- 1805571295
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2019
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Lactase Deficiency, Symptoms of Lactose Intolerance, and the Small Intestinal Microbiome in Adults
- ClinicalTrials.gov ID
- NCT03860051
- Acronym / sponsor ID
- 1805571295
- Conditions
- Lactose Intolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 1 Mar 2019 (actual)
- 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.
The purpose of this study is to study the role of the enzyme (substance produced by the body that helps in a biochemical reaction like digestion in the body) responsible for digestion of lactose and the role of the gut bacteria (bacteria in the intestine) in producing symptoms of lactose intolerance.
Detailed description
The study involves 3 visits and will include 2 types of subjects - those who have the the diagnosis of lactose intolerance (subjects) and those who do not have lactose intolerance (controls).
Visit 1:
In total, it is estimated that the research participation will add about 1 hour to your planned procedure visit. At Visit 1 following will be done
- Subjects will be asked to read and sign the informed consent after all the questions about the study have been answered.
- General medical history will be taken including demographics, symptoms and history of illness, and medication review.
- Vital signs (blood pressure, temperature, respiration, height, and weight) will be recorded.
- Subjects will be asked to complete 2 questionnaires
- Upper endoscopy will be done as part of routine clinical care
- At the time of the endoscopy 4 extra biopsies (small piece of tissue) from the small intestines will be taken. The biopsies will be used for research to detect the bacteria and to measure the lactase enzyme.
- Small sample of blood (10 mL) (2 teaspoons) will be taken for storage for possible future testing. This will be a one time draw only.
- The research team may contact the subjects to arrange a Visit 2 if they are interested in proceeding with the next step in this research study.
Visit 2:
Visit 2 will take approximately 6 hours to complete. If the subject returns for Visit 2, they will do the following
- They will return to the research office at Indiana University to participate in hydrogen breath test (test that uses the measurement of hydrogen in the breath to diagnose several conditions) to see how the body reacts to lactose. This involves drinking milk, then blowing into a bag so we can collect breath samples. Subjects will be asked to report any symptoms they might have during this time. This test will take approximately 6 hours. They will be instructed to eat a low-fiber meal the night before the test, and asked to fast for the 12 hours before the test. They can drink water during this time.
- They will be also be asked to provide a stool sample for future analysis. Instructions for collection, storage and transportation of stool will be provided. They will be provided a kit for stool collection, storage and transportation. They will be asked to collect stool at home over the course of 2 days and store as per instructions. Stool will need to be refrigerated and brought back to the office on ice.
Visit 3:
Visit 3 will take approximately less than one hour to complete. For those who are interested in returning for Visit 3,
- Subjects will be asked to return to the clinic with the stool samples.
- They will complete the study at this time.
Participants who complete Aim 1 and meet further eligibility criteria for Aim 2 may be contacted by research staff to return for Visit 2 (breath test). Those who are agreeable to participating and are scheduled for Visit 2 will be instructed to consume a low-fiber meal and fast for 12 hours prior to their breath test. We will contact the participant 24 to 48 hours prior to the test day as a reminder to consume a low fiber meal and fast for 12 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient ages 18-75 presenting for upper gastrointestinal endoscopy for any indication except those outlined in the exclusion criteria below at the IU GI Endoscopy Sites including: IU North Hospital, Glen Lehman Endoscopy Suite, Springmill/Beltway Surgery Center, IU Saxony, and Eskenazi Hospital will be eligible for participation. Participants should be willing and able to sign informed consent.
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Patients with known bleeding diathesis given the need for small intestinal mucosal biopsies.
- Patients with known history of eosinophilic esophagitis, inflammatory bowel disease, chronic pancreatitis or pancreatic insufficiency, celiac disease, peptic duodenitis
- Antibiotic-use within the last 30 days
- Major abdominal surgery except appendectomy or cholecystectomy > 6 months prior to enrollment
- Prior radiation therapy of the abdomen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactase activity
Time frame: 1 day
Lactase activity (µmol/min/g) will be assessed from small bowel biopsy specimens
4 secondary outcomes
Symptom severity
Time frame: 1 day
Small intestinal mucosal microbiome
Time frame: 1 day
Maldigestion status
Time frame: 1 day
Fecal microbiome
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Andrea S Shin, MD principal investigator
IU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactose Intolerance, run by Indiana University at 1 site in United States.
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 0 inclusion and 17 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: finished, as of the sponsor's last update on 6 Mar 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactase activity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2024.