Probiotic for Lactose Intolerance

Overseen By Dennis Savaiano, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Purdue University

Must not be taking: Antacids, PPIs, Antibiotics, others

Disqualifiers: Diabetes, HIV, IBD, others

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a daily capsule containing the probiotic Bifidobacterium adolescentis IVS-1 can help individuals with lactose intolerance digest dairy more effectively by altering their gut bacteria. Participants will take either this probiotic or a placebo (a pill with no active ingredient) to determine if their symptoms, such as gas and bloating after consuming dairy, improve. Suitable candidates are those who have self-reported lactose intolerance and are willing to refrain from other lactose intolerance treatments during the study. As an unphased trial, this study provides an opportunity to contribute to scientific understanding and potentially enhance personal lactose digestion.

Will I have to stop taking my current medications?

The trial requires participants to stop using treatments and products for dairy intolerance, like Lactaid® and probiotics, during the study. If you are using these, you will need to refrain from them while participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Bifidobacterium adolescentis IVS-1 is generally safe for people. In studies, individuals who took this probiotic for two weeks experienced improved lactose tolerance. It reduced issues like diarrhea and the urgent need to use the bathroom, common in lactose intolerance.

This probiotic has been well-researched and helps balance gut bacteria and improve calcium absorption. No serious side effects have been reported, indicating that Bifidobacterium adolescentis IVS-1 is well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for lactose intolerance, which often involve enzyme supplements like lactase pills, the Bifidobacterium adolescentis IVS-1 capsule offers a novel approach by using probiotics. This treatment introduces a specific strain of bacteria that may improve gut health and enhance lactose digestion in a natural way. Researchers are excited because this could provide a more sustainable and holistic option, potentially reducing the need for enzyme supplements and offering better tolerance for lactose-containing foods.

What evidence suggests that Bifidobacterium adolescentis IVS-1 could be effective for lactose intolerance?

Research has shown that Bifidobacterium adolescentis IVS-1, which participants in this trial may receive, can aid those who are lactose intolerant. One study found that individuals taking this probiotic experienced fewer symptoms, such as diarrhea and stomach urgency, compared to those on a placebo. Additionally, these individuals handled lactose better overall. This suggests that the probiotic might alter gut bacteria to help the body process lactose more effectively. Overall, early findings are promising for those who struggle with lactose digestion. ^{1 6 7 8 9}

Who Is on the Research Team?

Dennis Savaiano, PhD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who self-report lactose intolerance or maldigestion, can avoid lactose and certain treatments during the study, and are willing to complete all procedures. Excluded are those with severe gastrointestinal conditions, recent surgeries affecting digestion, high BMI (>35), active ulcers, pregnancy, chemotherapy patients, and those with immune diseases.

Inclusion Criteria

You have reported that you have trouble digesting lactose or are lactose intolerant.

I am willing and able to give my consent to participate.

Agrees to refrain from all other treatments and products used for dairy intolerance (e.g., Lactaid®, Dietary Supplements, probiotics) during study involvement

Exclusion Criteria

I have not had a high colonic enema in the last 30 days.

Use of any investigational drug or participation in any investigational study within 30 days prior to screening

Any other conditions/issues noted by the study staff and/or Principal Investigator that would impact participation and/or protocol compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (phone screening)

Part 1: Lactose Avoidance and Initial Testing

Participants avoid lactose intake and undergo initial hydrogen breath test and symptom rating

14 days

1 visit (in-person for breath test)

Part 2: Intervention

Participants take either a bifidus capsule or placebo while continuing to avoid dairy foods

13 days

1 visit (in-person for breath test)

Part 3: Return to Normal Diet

Participants resume normal diet including dairy foods and continue symptom rating

14 days

1 visit (in-person for stool sample)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bifidobacterium adolescentis IVS-1 capsule
• Placebo cellulose capsule

Trial Overview The trial tests if a Bifidobacterium adolescentis capsule improves lactose digestion in intolerant individuals compared to a placebo. It aims to see if this probiotic can change the gut microbiome to better handle dairy products.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Daily Bifidobacterium adolescentis IVS-1,capsule

Group II: Control Group Placebo Group 1 Intervention

Daily cellulose capsule

Who Is Running the Clinical Trial?

Purdue University

Lead Sponsor

Trials

239

Recruited

72,200+

Published Research Related to This Trial

A study involving 221 healthy infants aged 3 to 12 months found that three probiotic strains (Bifidobacterium longum subsp. infantis R0033, Bifidobacterium bifidum R0071, and Lactobacillus helveticus R0052) were safe and well tolerated over an 8-week period, with no serious adverse events reported.

Growth measurements (weight, height, and head circumference) were similar across all groups, indicating that these probiotics do not negatively impact infant growth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial. Manzano, S., De Andrés, J., Castro, I., et al.[2018]

In a study of 44 infants with functional chronic constipation, supplementation with Lactobacillus reuteri (DSM 17938) significantly increased the frequency of bowel movements compared to a placebo at weeks 2, 4, and 8.

While L reuteri improved bowel movement frequency, it did not significantly change stool consistency or reduce inconsolable crying episodes, indicating its specific efficacy in enhancing bowel regularity without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. Coccorullo, P., Strisciuglio, C., Martinelli, M., et al.[2022]

Citations

1. tandfonline.com tandfonline.com/doi/full/10.1080/29933935.2025.2508199

Full article: Two-week supplementation of Bifidobacterium ... The iVS-1 group reported less overall daily symptoms during the treatment period when compared to placebo (p = 0.032) and had significant improvement for fecal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05668468

A Bifido Bacteria to Improve Lactose Digestion and Tolerance Supplementation with Bifidobacterium can change the colonic microflora to improve lactose digestion, and changes in the gut microbiome can mediate lactose ...

3. medrxiv.org medrxiv.org/content/10.1101/2024.12.16.24319107v1

Two-week supplementation of Bifidobacterium ... Two-week supplementation of Bifidobacterium adolescentis iVS-1 reduces fecal urgency and diarrhea and enhances overall lactose tolerance in lactose ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/29933935.2025.2508199

Two-week supplementation of Bifidobacterium ... The iVS-1 group reported less overall daily symptoms during the treatment period when compared to placebo (p = 0.032) and had significant improvement for fecal ...

5. researchgate.net researchgate.net/publication/392416886_Two-week_supplementation_of_Bifidobacterium_adolescentis_iVS-1_reduces_symptoms_associated_with_lactose_intolerance_in_lactose_maldigesters

Two-week supplementation of Bifidobacterium ... Two-week supplementation of Bifidobacterium adolescentis iVS-1 reduces symptoms associated with lactose intolerance in lactose maldigesters ... Data ...

6. medrxiv.org medrxiv.org/content/10.1101/2024.12.16.24319107v1.full-text

Two-week supplementation of Bifidobacterium ... Two-week supplementation of Bifidobacterium adolescentis iVS-1 reduces fecal urgency and diarrhea and enhances overall lactose tolerance in lactose ...

7. synbiotichealth.com synbiotichealth.com/wp-content/uploads/2024/10/iVS-1_Brochure.pdf

Experience Healthy Aging with B. adolescentis A probiotic strain that efficiently digests lactose can alleviate lactose intolerance symptoms, improve calcium absorption, maintain gut bacteria balance, ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/condition/752/lactose-intolerance

Lactose Intolerance Clinical Research Trials Bifidobacterium adolescentis IVS-1 presents a unique opportunity to evaluate both species and dose of a very well characterized probiotic in improving lactose ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5983828/

Safety Evaluations of Bifidobacterium bifidum BGN4 and ... It is commonly agreed that microbial safety should demonstrate the (i) species characteristics with genetic information, (ii) phenotypic evidence, (iii) ...