Irritable BowelNCT04214470

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in IBS

An observational study of Irritable Bowel and Irritable Bowel Syndrome, run by ProgenaBiome at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records. Read more about this study

Who is it for?: Any age
Conditions the study is for: Irritable Bowel, Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 2 Mar 2020to Jul 2030
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with IBS

Who may be able to join

Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
Male or female of all ages
Diagnosis of IBS

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

ProgenaBiome
Ventura, California, 93003

Other trials in United States

About this study

Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Irritable Bowel Syndrome

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

Read the detailed description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to IBS.

Conditions: Irritable Bowel, Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome Mixed, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Without Diarrhea
Being tested: No intervention
Medical subject headings: Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
There is no intervention for this study

Study groups in NCT04214470
Study group	Role	What they receive
Irritable Bowel Syndrome Patients		Patients with IBS. Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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 with diabetes mellitus
Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 2020Jul 2030

First posted2 Jan 2020
Study start2 Mar 2020
Primary completionMar 2030 (estimated)
Study completionJul 2030 (estimated)

Why it stopped: Company shifted focus

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Irritable BowelStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04214470
Sponsor's protocol ID: PRG-036
Status last verified: Jun 2025
First submitted: 27 Dec 2019
Last updated: 5 Jun 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is no plan to share IPD.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin

All Irritable Bowel trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT04214470
Acronym / sponsor ID: PRG-036
Conditions: Irritable Bowel, Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome Mixed, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Without Diarrhea
Study type: Observational
Recruitment status: WithdrawnReason stopped: Company shifted focus
Enrolment: 0 participants (actual)
Lead sponsor: ProgenaBiomeUniversity, hospital or other
Study start: 2 Mar 2020 (actual)
Primary completion: Mar 2030 (estimated)
Study completion: Jul 2030 (estimated)
First posted: 2 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to IBS.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Irritable Bowel Syndrome Patients	–	Other: No interventionPatients with IBS.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with IBS

Key inclusion criteria (4 listed)

Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
Male or female of all ages
Diagnosis of IBS

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionThere is no intervention for this study	Other	Irritable Bowel Syndrome Patients

Primary outcome

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
Time frame: Three years
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 with diabetes mellitus

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
Individual participant dataSharing planned: No. There is no plan to share IPD.

Related trials for Irritable Bowel

Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sabine Hazan principal investigator

ProgenaBiome

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Irritable Bowel and Irritable Bowel Syndrome, run by ProgenaBiome at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing (time frame: Three years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04214470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.