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Lactose IntoleranceNCT02171403

Comparison of the Colonic Metabolism in Patients With Lactose Intolerance and Healthy Controls

An observational study of Lactose Intolerance, run by KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Most people are born with the ability to digest lactose, a dissacharide consisting of β-D-glucose and β-D-galactose, because of the presence of lactase at the brush border of the small intestine. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Lactose Intolerance
How many people
34 participants
Where
1 siteBelgium
Study dates
Jun 2014to Mar 2015
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with a positive test (reduced lactose digestion and increased H2-excretion) and complaints will be included in the group of lactose-intolerant patients and patients with a positive result without complaints will be included in the group of lactose-malabsorption patients. Subjects with a normal breath test will be recruited as controls.

Who may be able to join

  • healthy or positive lactose breath test
  • > 18 Year
  • 18 kg/m²<BMI<27.5 kg/m²
  • regular dietary pattern

Who cannot join

  • intake of antibiotics 1 month prior to sample collection
  • abdominal chirurgical intervention except appendectomy
  • intake of medication 14 days prior to sample collection
  • vegetarian
  • intake of pre- or probiotics

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • TARGID, KU Leuven

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

About this study

Most people are born with the ability to digest lactose, a dissacharide consisting of β-D-glucose and β-D-galactose, because of the presence of lactase at the brush border of the small intestine. In about 75% of the world population the activity of this enzyme decreases after weaning (primary hypolactasia or lactase-nonpersistence), resulting in incomplete digestion of lactose and lactose malabsorption in adulthood (1). Secondary forms of lactose malabsorption may be due to inflammation or functional loss of the intestinal mucosa such as celiac disease, infectious enteritis or Crohn's disease. Very rarely, lactase deficiency is congenital due to an autosomal recessive genetic disorder, preventing lactase expression from birth (2). Whereas some people with lactose malabsorption are asymptomatic, most lactose-nonpersisters experience symptoms like abdominal pain, bloating, excess flatulence or diarrhea. Lactose intolerance refers to the syndrome of having one or more symptoms after consumption of lactose-containing food (3). At present, the origin of the symptoms of lactose-intolerance is not well understood.

Several studies have indicated a poor correlation between lactose maldigestion and symptoms of lactose intolerance (4). In a study by Vonk et al. (2003), lactose intolerant subjects with severe symptoms (diarrhea) and intolerant subjects with only mild symptoms (without diarrhea) did not differ in degree of lactose digestion in the small intestine indicating a similar lactase activity and leading them to the hypothesis of a "colon resistence factor" (5). It was suggested that the colonic processing of maldigested lactose may play a role in the symptoms experienced by lactose intolerant patients. When lactose is malabsorbed and enters the colon, it is rapidly fermented by the resident microbiota into a variety of metabolites including lactate, formate, succinate and short chain fatty acids (SCFA, acetate, propionate, butyrate) as well as gases (H2, CO2 and CH4). When incubating fecal samples from lactose-tolerant and intolerant subjects with lactose, the samples from the lactose-intolerant subjects showed faster production rates of D- and L-lactate, acetate, propionate and butyrate, as compared to tolerant subjects (6). Although the colon is thought to possess a high capacity to absorb SCFA, it was hypothesized that a temporary accumulation of these metabolites due to rapid fermentation of maldigested lactose could be responsible for abdominal pain, excess flatulence and bloating (7;8). Possible mechanisms proposed to explain how SCFA might induce symptoms included an increase in the osmotic load that draws fluid to the colonic lumen, changes in colonic motility and an increased colonic sensitivity (9-11). However, the calculated amount of fluid drawn in the colon is unlikely to cause symptoms considering the high water absorbing capacity of the colon and the effect of SCFA on colonic motility and colonic sensitivity have only been observed in rats and not in humans.

Read more

More recently, Campbell et al. introduced the bacterial metabolic toxin hypothesis, stating that also other bacterial metabolites, such as alcohols, aldehydes, acids and ketones, resulting from carbohydrate fermentation play a role in the pathogenesis of lactose-intolerance. These metabolites might inhibit bacterial growth and affect eukaryotic cells (12). In our own previous studies in which we related colonic fermentation patterns to parameters of cytotoxicity, we identified compounds like propionic acid, medium chain fatty acids, 1-octanol and heptanal as more prevalent in the most cytotoxic samples (13), supporting the hypothesis of Campbell et al. Therefore, it seems necessary to include not only SCFA, but also other metabolites, in the investigation of the pathogenesis of lactose intolerance.

Differences in fermentation patterns might be associated with differences in the composition and/or activity of the intestinal microbiota. Evidence on the potential role of the colonic microbiota in lactose intolerance is very limited. Total bacterial numbers were not significantly different between 16 intolerant and 11 tolerant lactose maldigesters although a negative correlation between total bacteria and symptom score was found (14). Similarly, the composition of fecal microbiota was not different between 5 intolerant and 7 tolerant subjects (6).

Read the detailed description

In this study we will compare colonic fermentation and parameters of gut health (fecal water cytotoxicity) between patients who are lactose intolerant, patients who have lactose malabsorption and healthy subjects.

Medical subject headings
Lactose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02171403
Study groupRoleWhat they receive
Lactose intolerancePatients with a positive lactose-breath test and complaints during the test
Lactose malabsorptionPatients with a positive lactose-breath test and no complaints during the test
Healthy controlsSubjects with a negative lactose-breath test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fecal water genotoxicity

    Fecal water, prepared by ultracentrifugation of fecal samples, will be incubated with HT-29 cells, a colonic adenocarcinoma cell line. Fecal water genotoxicity will be assessed using the Comet Assay, a sensitive method to detect DNA damage at the level of the individual eukaryotic cell. During the Comet Assay, the cells undergo electrophoresis causing movement of the damaged DNA out of the nucleus. The amount of DNA damage will be determined by measuring the extent the DNA has moved out of the nucleus, using fluorescent microcropy and dedicated software.

    Measured: 1 day

Secondary outcomes (1)
  1. fecal water cytotoxicity

    Fecal water cytotoxicity will be measured using the WST-1 assay, a colorimetric test based on the conversion of the tetrazolium salt WST-1 by cellular mitochondrial dehydrogenases present in viable cells. The dilution of fecal water at which 50% of the cells survive will be determined. The higher the dilution, the more cytotoxic the sample is.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

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
Case-control
Time perspective
Prospective
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02171403
Sponsor's protocol ID
B322201421130
Other IDs
ML10399
Status last verified
Jul 2015
First submitted
18 Jun 2014
Last updated
29 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lactose Intolerance, run by KU Leuven at 1 site in Belgium.

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 4 inclusion and 5 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 29 Jul 2015. 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 Belgium. 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?

fecal water genotoxicity (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 29 Jul 2015.

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