An interventional study of Dietary intervention in Milk Intolerance, sponsored by University of Turku. Completed at 1 site in Finland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by University of Turku · Not applicable, Interventional, and Basic science
The aim of this study is to reveal how different forms of milk casein, lactose and moderate breakdown of proteins affect the symptoms that may arise from milk and markers of inflammation in volunteers receiving symptoms from milk. Research hypotheses are: 1) Protein hydrolyzed milk is as tolerated or better tolerated than A2 milk, and 2) Lactose is the main causative agent of stomach symptoms in milk-sensitive individuals.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 37 is close to the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →University of Turku is the lead sponsor of 122 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A2 whole milk, 3.5% fat, heat-treated; placebo capsule without enzyme
Other: Dietary intervention
A2 whole milk, 3.5% fat, heat-treated; lactase capsule
Other: Dietary intervention
Protein-hydrolyzed lactose-free milk, 3% fat, heat-treated; placebo capsule without enzyme
Other: Dietary intervention
The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.
Changes from baseline in Inflammation marker IL-4
IL-4 (interleukin 4) is measured from fasting plasma samples at the baseline before the study and then after each 3-day study arm on the 4th day. It will be analysed as part of the Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden) that provides absolute quantities for 45 different proteins, such as interleukins, interferons, chemokines and growth factors that are related to inflammation. Differences in plasma inflammation marker is measured as a baseline
Time frame: after treatment (4th day)
Changes from Baseline in Inflammation markers
Inflammation markers of 45 different proteins, such as interleukins, interferons, chemokines and growth factors are measured from fasting plasma samples as a baseline before the study and then on the 4th day after each 3-day study arm. The absolute quantities of the markers will be analysed with Olink Target 48 Cytokine Panel (Olink Proteomics, Uppsala, Sweden). Differences in inflammation markers (from plasma)
Time frame: after treatment (4th day)
Changes from Baseline in Calprotectin
Faecal calprotectin (from faecal sample) is used to measure inflammation status of the gut. Participants collect the first stool of the day in a collection tube and bring it to the study facility in a cooled bag after each study arm.
Time frame: after treatment (4th day)
Changes from Baseline in Stool types and Bowel movements
The changes in bowel movements and stool consistency are recorded using a defecation record with the 7-step Bristol stool chart during the consumption of milks (on each study arm). Participant will record the time of the bowel movement and the dominant type of the stool. The Bristol types will be categorized as hard (types 1 and 2), normal (types 3, 4, and 5), or loose stools (types 6 and 7).
Time frame: 3 days during the treatment
Changes from Baseline in Gastrointestinal symptoms
Gastrointestinal symptoms (self-reported) as measured by a questionnaire. The questionnaire is divided into seven types of gastrointestinal discomfort, and also includes a possibility to describe a gastrointestinal discomfort outside these seven given alternatives. The severity of the symptoms is self-reported on a three-step scale. Participants fill the questionnaire during 3 days on the baseline and on each study arm (treatment).
Time frame: 3 days during the treatment
Changes from Baseline in high-sensitivity CRP
Inflammation marker high-sensitivity CRP is measured from fasting plasma samples as a baseline before the study and then on the 4th day after each 3-day study arm.
Time frame: after treatment (4th day)
Plan to share: No — Sensitive volunteer data may only be shared for collaborative research purposes with a separate agreement with the data owner.
Ran from May 2022 to primary completion in Mar 2023, 9 months.
Of 22 interventional studies with no phase under Lactose Intolerance, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 9 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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