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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to see if a special type of beneficial bacteria can help people who have trouble digesting lactose. The bacteria, Bifidobacterium adolescentis IVS-1, is given to participants to see if it can improve their ability to digest dairy products and reduce discomfort. The study focuses on people with lactose intolerance and tests how well this bacteria works in their gut.

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.

What data supports the effectiveness of the treatment Bifidobacterium adolescentis IVS-1 capsule for lactose intolerance?

Research suggests that certain probiotics can help reduce symptoms of lactose intolerance by improving gut health. For example, a study found that probiotics like Bifidobacterium longum can decrease bloating and improve digestion in lactose intolerant individuals. ^{1 2 3 4 5}

Is the probiotic treatment for lactose intolerance safe for humans?

A study on the safety of three probiotic strains, including Bifidobacterium species, in healthy infants showed no serious adverse events and similar growth patterns compared to a placebo, indicating they are safe and well-tolerated. ^{1 6 7 8 9}

How is the probiotic Bifidobacterium adolescentis IVS-1 different from other treatments for lactose intolerance?

Bifidobacterium adolescentis IVS-1 is a probiotic treatment that may help reduce symptoms of lactose intolerance by improving gut health, which is different from traditional treatments like lactase enzyme supplements that directly aid in lactose digestion. ^{3 4 6 10 11}

Research Team

Dennis Savaiano, PhD

Principal Investigator

Purdue University

Eligibility Criteria

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 between 18 and 65 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy of i3.1 Probiotic on Improvement of Lactose Intolerance Symptoms: A Randomized, Placebo-controlled Clinical Trial. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Bifidobacterium longum and Lactobacillus rhamnosus on Gut Microbiota in Patients with Lactose Intolerance and Persisting Functional Gastrointestinal Symptoms: A Randomised, Double-Blind, Cross-Over Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Do probiotics reduce adult lactose intolerance? A systematic review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

The use of probiotics and prebiotics can enable the ingestion of dairy products by lactose intolerant individuals. [2023]

5. China pubmed.ncbi.nlm.nih.gov

[Effect of probiotics and yogurt on colonic microflora in subjects with lactose intolerance]. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Adjunctive efficacy of Lactis XLTG11 for Acute diarrhea in children: A randomized, blinded, placebo-controlled study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Safety evaluation of Bifidobacterium pseudocatenulatum G4 as assessed in BALB/c mice. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Lactobacillus reuteri (DSM 17938) in infants with functional chronic constipation: a double-blind, randomized, placebo-controlled study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and tolerance of three probiotic strains in healthy infants: a multi-centre randomized, double-blind, placebo-controlled trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Efficacy of Bifidobacterium infantis 35624 in patients with irritable bowel syndrome: a meta-analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Benefit of the Probiotic Bifidobacterium infantis 35624 in Non-Patients With Symptoms of Abdominal Discomfort and Bloating. [2018]