An interventional study of Bifidobacterium adolescentis IVS-1 capsule and Placebo cellulose capsule in Lactose Intolerance, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Purdue University · Not applicable, Interventional, and Other
We want to determine if feeding a bifido bacteria that readily digests lactose and galactooligosacharides improves lactose digestion and tolerance through alteration of the microbiome.
Bifidobacterium adolescentis IVS-1, is a strain of the bacterial species Bifidobacterium adolescentis that has been thoroughly characterized. It is deposited with the American Type Culture Collection (ATCC®) under Patent Deposit Designation as PTA-120614. B. adolescentis IVS-1 is part of the broader group of bacteria within the genus. These bacteria are one of the major genera of microorganisms that make up the gastrointestinal tract microbiota in mammals. Bifidobacterium is also long considered to contribute to a healthy gastrointestinal tract in infants as well as adults. These organisms have been used in food products and dietary supplements for decades, with a record of safe consumption. B. adolescentis IVS-1 is a specially selected strain. Krumbeck et. al. isolated bifidobacteria from fecal samples of human individuals who had consumed the prebiotic GOS during a previous human trial. For this isolation, a combination of approaches was used to select a candidate strain (B. adolescentis strain IVS-1) enriched by GOS in vivo. The subject consumed increasing doses of GOS for nine weeks. A retrospective analysis of the fecal microbiota of one subject revealed an 8-fold enrichment in B. adolescentis strain IVS-1 during GOS administration. Thus, the strain originated from a subject who showed a strong bifidogenic response to GOS. The functionality of GOS to support the establishment of IVS-1 in the gastrointestinal tract was then evaluated in rats. Strain-specific quantitative real-time PCR showed that the addition of GOS increased B. adolescentis IVS-1 abundance in the distal intestine by nearly two logs. Illumina 16S rRNA sequencing not only confirmed the increased establishment of IVS-1 in the intestine but also revealed that the strain was able to outcompete the resident Bifidobacterium population when provided with GOS. The preparation containing Bifidobacterium adolescentis IVS-1 is manufactured at Centro Sperimentale Del Latte srl, Strada Provinciale per Merlino, 3, 26839, 26839 Zelo Buon Persico LO, Italy, in accordance with current good manufacturing practices (cGMPs); approved and recognized by Global Food Safety Initiative. The facility is FSSC 2200 certified.
Bifidus and lactose intolerance:
The use of probiotics, including Bifidobacterium, has had mixed success in improving lactose tolerance. The failures are likely due to dose and strain, as demonstrated in our lab. Supplementation with Bifidobacterium can change the colonic microflora to improve lactose digestion, and changes in the gut microbiome can mediate lactose intolerance symptoms as first shown in our lab and more recently by others. Bifidobacterium adolescentis IVS-1 presents a unique opportunity to evaluate both species and dose of a very well characterized probiotic in improving lactose digestion, altering the microbiome, and improving lactose tolerance.
Study Procedures:
Participants will undergo a pre-Informed Consent phone screening for eligibility. Informed Consent will be obtained. Demographic/ contact information and a departmental Subject Payment Form will be completed. Study staff contact information and study information handout will be provided. Consented participants will then undergo an abbreviated hydrogen breath test (3 hours duration) which involves drinking 8 oz. of 2% fat commercial milk and giving a breath sample and rating any symptoms they might have at 1 and 2 hours post milk dose. Participants who register a hydrogen value of 20ppm or above will be eligible to proceed to Part 1 of the study.
PART 1: On study:
Days 1-13: Participants will be instructed to avoid lactose intake (i.e. milk in any form, fluid or soft dairy foods, etc.) Participants will be asked to rate any symptoms that are generally associated with lactose intolerance they might be experiencing once daily. This information will be returned daily to study staff electronically, or can be returned to the Clinical Research Center.
Day 11, 12 or 13: Provide a stool sample. Participants can provide this sample on one of the days listed. A range is given to account for participants who may not have a bowel movement daily. Participants will be given a labeled container for stool collection, and return the container to the Clinical Research Center.
Day 14: Eight hour hydrogen Breath Test: Participants will fast for 12 hours prior to the test and the last meal eaten before fasting will be a low fiber meal. Participants will be given food grade lactose in water containing 0.5g lactose per kg body weight (12g per 240ml cup) with a maximum of 50g of lactose. Breath samples will be taken at the following time points: 0 (pre-milk dose), 30 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, and 8 hours for a total of ten (10). Participant will record any symptoms they experience related to lactose intolerance at these same time intervals using provided forms. Participants will be randomized to receive either a daily bifidus capsule (containing up to 5x10 ninth cfu per capsule) or a placebo capsule containing cellulose (Days 15-27).
PART 2: On Study: Days 15-27:
Participants continue to avoid dairy foods. Participants will daily take either a bifidus capsule or a cellulose capsule. Participants will be asked to rate any symptoms that are generally associated with lactose intolerance they might be experiencing once daily.
Day 25, 26, or 27: Provide a stool sample.
Day 28: Eight hour hydrogen breath test:
PART 3: Days 29-43:
Participants will resume their normal diet including dairy foods and will continue to rate symptoms that are associated with lactose intolerance once daily.
Day 40, 41, or 42: Provide a stool sample.
Human subjects recruitment, blinding, and protection:
Staff who interact with subjects will be blinded to treatments. Recruitment efforts include flyers, social media ads, and other local print media. Participant information will be accessible only by study staff. Phone calls will be done in an area allowing for privacy. Research visits will be in the Purdue Clinical Research Center. Risk of breach of confidentiality is possible. Measures will be taken to minimize this risk. Individuals volunteering to participate in this study will be assigned a Subject Identification Number (SID) for data entry and Case Report Form completion. The linking information will be held by the study staff, in a locked file cabinet, in a locked office, and destroyed when the study/publication timeline is completed. Data will be stored both via hard copy and electronically. Hard copies will be stored in a locked file cabinet, in a locked office (Stone Hall, Purdue University, West Lafayette). Electronic data will be maintained in a secure folder, on a secure Purdue server. Only the Principal Investigator and study staff will have access to participant data. Information collected for payment purposes (name, address, social security number) will be provided to the business office, Purdue University for the purpose of facilitating payment. This information will be kept in a locked filing cabinet. No additional identifier will be provided with this information (i.e. Subject Identification Number), so there will be no way of matching this information to their data. All research records and data will be stored for a minimum of 3 years. Records and data will be stored until all analysis/publication activity has ceased.
53 studies on the registry are indexed under Lactose Intolerance; 6 are open to participants now.
This study's enrollment of 24 is below the median of 41 across 41 interventional studies indexed under Lactose Intolerance.
Browse Lactose Intolerance studies →Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.
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Ability/desire to provide
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily cellulose capsule
Other: Placebo cellulose capsule
Daily Bifidobacterium adolescentis IVS-1,capsule
Dietary Supplement: Bifidobacterium adolescentis IVS-1 capsule
Daily Bifidobacterium adolescentis IVS-1 capsule containing up to 6x10 ninth cfu per capsule or daily cellulose capsule
Daily cellulose capsule
Bifidus feeding will change lactose digestion
difference in lactose maldigestion as measured by breath hydrogren following a lactose challenges on day 14 and day 28.
Time frame: 14 days
Bifidus feeding will change lactose intolerance symptoms
differences in symptoms of flatulence, stomach discomfort, and diarrhea following lactose challenges on day 14 and day 28
Time frame: 14 days
daily symptoms of lactose intolerance will be minimal following return to normal diet
daily recording of lactose intolerance symptoms days 29-43 as compared to the control feeding
Time frame: 14 days
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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