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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to study the effect of probiotics on gut function in subjects with occasional constipation. The main question it aim to answer is if intake of probiotics will decrease the transit time. Participants will randomized to either consume probiotics or a placebo product.

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 data supports the effectiveness of the treatment Probiotics, Live Microorganisms, Beneficial Bacteria, Gut Microbiota Supplements for occasional constipation?

Research shows that probiotics, including strains like Lactobacillus and Bifidobacterium, can help improve symptoms of constipation by increasing bowel movements and improving stool consistency. Studies have found that these beneficial bacteria can change the gut microbiota in a way that supports better digestive health and reduces constipation symptoms. ^{1 2 3 4 5}

Is it safe to use probiotics for occasional constipation?

Research on probiotics for constipation shows no significant safety concerns, indicating they are generally safe for human use. ^{1 2 6 7 8}

How do probiotics differ from other treatments for occasional constipation?

Probiotics are unique because they use beneficial bacteria to improve gut health and alleviate constipation by enhancing stool frequency and altering gut microbiota composition, unlike traditional treatments that may rely on laxatives or fiber supplements. ^{1 2 4 6 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of microbial cell preparation in improving chronic constipation: a randomized, double-blind, placebo-controlled trial. [2022]

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

Systematic review of randomised controlled trials: probiotics for functional constipation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of the probiotic strain, Lactiplantibacillus plantarum P9, on chronic constipation: A randomized, double-blind, placebo-controlled study. [2023]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Differential Effects of Lactobacillus casei Strain Shirota on Patients With Constipation Regarding Stool Consistency in China. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Spore-forming Bacillus coagulans SNZ 1969 improved intestinal motility and constipation perception mediated by microbial alterations in healthy adults with mild intermittent constipation: A randomized controlled trial. [2021]

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

Effects of Probiotic Use on Quality of Life and Physical Activity in Constipated Female University Students: A Randomized, Double-Blind Placebo-Controlled Study. [2020]

8. Turkey pubmed.ncbi.nlm.nih.gov

Effects of a kefir supplement on symptoms, colonic transit, and bowel satisfaction score in patients with chronic constipation: a pilot study. [2015]

9. Italy 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. [2015]