Probiotics for Occasional Constipation

Overseen By Nisrine Zakaria

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Probi AB

Disqualifiers: Chronic constipation, Diabetes, Cancer, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if probiotics (live microorganisms) can help people with occasional constipation by speeding up food movement through the gut. Participants will take either probiotics or a placebo to observe any noticeable differences. It suits those who are generally healthy, experience occasional constipation, and can maintain their usual lifestyle habits. As an unphased trial, this study allows participants to contribute to the scientific understanding of probiotics and digestive health.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it requires participants to maintain their current lifestyle habits, which might suggest you can continue your medications.

What prior data suggests that probiotics are safe for gut function?

Earlier studies have shown that probiotics can help with constipation by making stools easier to pass and balancing gut bacteria. Research involving over a thousand participants suggests that probiotics might be effective for this purpose.

Regarding safety, probiotics are generally well-tolerated and often used as dietary supplements. They are considered safe for most people. While serious side effects are rare, some individuals might experience mild digestive symptoms like gas or bloating initially. Overall, probiotics are regarded as safe for human use, especially since they are commonly used for digestive health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for occasional constipation, which often include fiber supplements, laxatives, and stool softeners, probiotics offer a unique approach. Probiotics work by introducing beneficial bacteria into the gut, which can help balance the microbiome and promote regular bowel movements naturally. Researchers are excited about probiotics because they target the root of digestive health rather than just alleviating symptoms. Additionally, probiotics are known for their mild side effect profile, making them a potentially safer and more gentle option for managing constipation compared to harsher chemical laxatives.

What evidence suggests that probiotics might be an effective treatment for occasional constipation?

Research shows that probiotics, which participants in this trial may receive, can help with constipation by making stools easier to pass and adjusting the balance of bacteria in the gut. In one study with 100 women, a supplement containing probiotics significantly improved the frequency and ease of bowel movements. Another study found that a mix of probiotics reduced constipation symptoms and enhanced the overall well-being of older adults with occasional constipation. Although research remains limited, probiotics have shown promise for those dealing with constipation. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who experience occasional constipation and want to explore if probiotics can help improve their gut function. Specific eligibility criteria are not provided, but typically participants must be in good general health with no conflicting medical conditions.

Inclusion Criteria

Healthy

Provided voluntary, written, informed consent to participate in the study

I agree to not change my current lifestyle habits.

Exclusion Criteria

I have had a major heart problem in the last 6 months.

Allergy, sensitivity, or intolerance to study products or clinical assessment materials

I have chronic constipation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to consume either probiotics or a placebo product for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Probiotics

Trial Overview The study is testing the effectiveness of probiotics versus a placebo (a harmless inactive substance) on improving gastrointestinal function in people with occasional constipation. Participants will be randomly assigned to one of the two groups.

How Is the Trial Designed?

Group I: Probiotics Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Probi AB

Lead Sponsor

Trials

23

Recruited

4,200+

Published Research Related to This Trial

A study involving 100 chronically constipated women showed that a synbiotic supplement (LACTOFOS®) significantly improved stool frequency and consistency compared to a placebo over 30 days.

The synbiotic treatment led to better constipation intensity scores, indicating its efficacy in managing constipation, while not affecting abdominal symptoms like pain or bloating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. Waitzberg, DL., Logullo, LC., Bittencourt, AF., et al.[2022]

Probiotic supplementation, particularly with strains like Bifidobacterium lactis and Lactobacillus casei, shows a positive effect on defecation frequency and stool consistency in adults with constipation, based on a review of five randomized controlled trials involving 377 subjects.

In children, the strain L. casei rhamnosus Lcr35 demonstrated benefits for constipation, while L. rhamnosus GG did not, indicating that not all probiotic strains are equally effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of randomised controlled trials: probiotics for functional constipation. Chmielewska, A., Szajewska, H.[2022]

In a study involving 636 patients with constipation-variant IBS, a symbiotic treatment combining the probiotic Bifidobacterium longum W11 and the prebiotic Fos Actilight significantly increased stool frequency from an average of 2.9 to 4.1 times per week.

The treatment also led to a notable reduction in abdominal pain and bloating, with severe symptoms decreasing from 62.9% to 9.6% for bloating and from 38.8% to 4.1% for abdominal pain, indicating both efficacy and safety in managing IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a symbiotic preparation on the clinical manifestations of irritable bowel syndrome, constipation-variant. Results of an open, uncontrolled multicenter study. Colecchia, A., Vestito, A., La Rocca, A., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10120550/

Effects of dietary fibers or probiotics on functional constipation ... Dietary fibers/probiotics may relieve constipation via optimizing gut microbiome, yet with limited trial-based evidences.

2. sciencedirect.com sciencedirect.com/science/article/pii/S240545772502889X

Impact of prebiotics and postbiotics in the management ... Prebiotics and some probiotics have already shown beneficial effects in constipation through improving stool consistency and modulating the gut microbiota.

3. withpower.com withpower.com/trial/phase-constipation-5-2024-b4109

Probiotics for Occasional Constipation · Info for Participants A study involving 100 chronically constipated women showed that a synbiotic supplement (LACTOFOS®) significantly improved stool frequency and consistency ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/19390211.2025.2507610

Full article: Efficacy of Probiotic Supplementation with ... The findings suggest the probiotic blend alleviated constipation symptoms and improved the mental well-being in older adults with occasional ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6517882/

Probiotics: If It Does Not Help It Does Not Do Any Harm. Really? Gut microbiota and probiotics ... Systematic review and meta-analysis of the effect of probiotic supplementation on functional constipation in children.

6. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/14598-probiotics

Probiotics: What They Are, Benefits & Side Effects Probiotics are live bacteria and yeasts that have beneficial effects on your body. You can take them as dietary supplements or use them as topical products.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4053917/

Microorganisms with Claimed Probiotic Properties As mentioned before Escherichia coli Nissle 1917 together with other probiotics have been proven to treat constipation [43] and inflammatory bowel disease [83].

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nbu.12334

Probiotics for human use - Sanders - 2018 - Nutrition Bulletin Probiotics have become a popular approach for managing digestive and immune health and are being recommended more frequently as effective therapeutic ...

9. nccih.nih.gov nccih.nih.gov/health/probiotics-usefulness-and-safety

Probiotics: Usefulness and Safety | NCCIH - NIH Constipation. A 2014 review of 14 studies (1,182 participants) of probiotics for constipation in adults showed some evidence of benefit, especially for ...