What side effects are associated with this type of intervention?

Common treatments for constipation include probiotics, fiber supplements, laxatives, and stool softeners. Probiotics are generally well-tolerated but can cause mild side effects such as gas, bloating, and abdominal discomfort. Fiber supplements, like psyllium or methylcellulose, can also lead to increased gas, bloating, and sometimes abdominal cramping, especially when first introduced. Laxatives, depending on their type (osmotic, stimulant, or bulk-forming), can cause side effects ranging from dehydration and electrolyte imbalances to dependency with long-term use. Stool softeners are usually mild but can occasionally cause stomach cramps and diarrhea.

What prior FDA approvals exist?

The FDA has approved several treatments for constipation, including medications like polyethylene glycol (MiraLAX), lubiprostone (Amitiza), and linaclotide (Linzess). These treatments primarily focus on increasing fluid in the intestines or stimulating bowel movements. While probiotics are not specifically FDA-approved for constipation, they are being studied for their potential to restore gut microbiota balance, which may help alleviate symptoms of constipation. Probiotics such as Lactobacillus and Bifidobacterium strains are commonly researched for their benefits in improving gut health and regularity.

What other types of research exist?

Promising novel alternatives to probiotics for constipation patients include: 1) Fecal Microbiota Transplantation (FMT), which has shown some efficacy in reducing IBS symptoms, though more research is needed to determine its long-term benefits and optimal dosing. 2) Synbiotics, which combine prebiotics and probiotics, have shown potential in improving gut health and reducing symptoms. 3) Dietary modifications, such as a low FODMAP diet, which can help manage symptoms by reducing fermentable carbohydrates that exacerbate gastrointestinal issues. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Probiotics for Childhood Constipation

N/A

Recruiting

Led By Susana D Collazo, MD

Research Sponsored by Connecticut Children's Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-28 days of study period

Awards & highlights

Study Summary

This trial will study if probiotics can help children with constipation feel better sooner, with fewer days of pain and quicker return to normal eating/drinking.

Who is the study for?

This trial is for children aged 6 months to 8 years who are experiencing acute constipation and have had fewer than three bowel movements in the past week. They must be able to communicate in English or Spanish, have a working email, and not have chronic medical conditions like IBD or thyroid disorders.Check my eligibility

What is being tested?

The study tests if adding Culturelle Probiotic + Fiber to standard treatment helps kids recover faster from acute constipation compared to a placebo. It measures time to normal stool frequency, days with abdominal pain, and return to normal eating/drinking.See study design

What are the potential side effects?

While probiotics are generally considered safe, potential side effects may include mild digestive symptoms such as gas or bloating. However, specific side effects related to this trial's intervention will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-28 days of study period

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-28 days of study period

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-28 days of study period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to normal frequency of stool after onset of constipation

Secondary outcome measures

Improvement in abdominal pain

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ProbioticExperimental Treatment1 Intervention

Participants in this study arm will be receiving a 28-day supply of probiotic.

Group II: PlaceboPlacebo Group1 Intervention

Participants in this study arm will be receiving a 28-day supply of placebo.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Probiotics are live microorganisms that help restore the balance of gut microbiota, which is crucial for improving bowel regularity and stool consistency. For constipation patients, an imbalanced gut microbiota can result in slower intestinal transit and harder stools. By enhancing the gut microbiota, probiotics can alleviate constipation symptoms, making bowel movements more regular and less painful.

Find a Location

Who is running the clinical trial?

Connecticut Children's Medical CenterLead Sponsor

73 Previous Clinical Trials

32,258 Total Patients Enrolled

Susana D Collazo, MDPrincipal InvestigatorConnecticut Children's Medical Center

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05734833 — N/A

Constipation Research Study Groups: Probiotic, Placebo

Constipation Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05734833 — N/A

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05734833 — N/A

~155 spots leftby Sep 2025

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