A Pilot Study to Explore the Role of Gut Flora in Chronic Constipation

NCT04148248 | Withdrawn

• 1 other identifier: PRG-018
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding chronic constipation

Conditions

Constipation; Constipation Chronic Idiopathic; Constipation - Functional; Constipation (Excl Faecal Impaction)

Outcome Measures

Primary Outcomes (1)

• Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing

  Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be categorized among specific gastrointestinal disease types.

  One year

Secondary Outcomes (1)

• Validation of Sequencing Methods

  One year

Study Arms (1)

Patients

Patients with a diagnosis of chronic constipation

Other: No intervention

Interventions

No intervention OTHER

There is no intervention for this study

Patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults and minors of any age with a diagnosis of chronic constipation.

You may qualify if:

• Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
• Male or female patients of any age (interest is given to children to compare with mothers)
• Diagnosis of chronic constipation

You may not qualify if:

• Refusal to sign informed consent form
• History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
• Postoperative stoma, ostomy, or ileoanal pouch
• Participation in any experimental drug protocol within the past 12 weeks
• Treatment with total parenteral nutrition
• Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
• Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stool Samples

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: March 2, 2020
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)