Crohn DiseasePhase 2NCT04254549

Rifaximin in Patients With Diabetic Gastroparesis

A Phase 2 study testing Rifaximin in people with Crohn Disease and Diabetic Gastroparesis, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Crohn Disease, Diabetic Gastroparesis
What is being tested?: Rifaximin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 14 Jun 2019to 11 Apr 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women adult patients, aged 18-75, with diabetic gastroparesis
Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours)

Who cannot join

Prior surgery to the stomach or esophagus
Known mechanical obstruction of the GI tract
Current or recent (< 4 weeks) use of opioids
Current/active use of cannabis
Current or recent (< 4 weeks) use of antibiotics
Current or recent use of antifungal agents (< 4 weeks)

Show all 9Show fewer

Prior treatment with rifaximin (< 1 year)
Uncontrolled diabetes with a HgbA1c > 12
Severe uncontrolled or untreated anxiety or depression.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Florida
Jacksonville, Florida, 32224

Other trials in United States

About this study

Official title: Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.

Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.

Conditions: Crohn Disease, Diabetic Gastroparesis
Being tested: Rifaximin, Placebo
Medical subject headings: Crohn Disease

What participants receive

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

RifaximinDrug
Also called TD-1473
550 mg by mouth three times daily for 14 days
PlaceboDrug
By mouth three times daily for 14 days

Study groups in NCT04254549
Study group	Role	What they receive
Intervention Treatment	Experimental	Subjects diagnosed with gastroparesis will receive Rifaximin Receives: Drug: Rifaximin
Placebo Group	Placebo comparator	Subjects diagnosed with gastroparesis will receive a placebo Receives: Drug: Placebo

What is being measured

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

Improvement in Bloating Based on Overall Questionnaire Scoring
Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention. Questionnaires used are the Quality of Life SF-36v2 Survey, Gastroparesis Cardinal Symptom Index Daily Diary, Hospital Anxiety and Depression Scale, and Nepean Dyspepsia Index.
Measured: From enrollment to end of treatment at 8 weeks.

Timeline

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

14 Jun 201911 Apr 2025

First posted5 Feb 2020
Study start14 Jun 2019
Primary completion8 Apr 2025
Study completion11 Apr 2025

Why it stopped: Sponsor discontinued placebo. Unable to meet enrollment goals.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn DiseaseStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04254549
Sponsor's protocol ID: 19-002908
Status last verified: Jun 2026
First submitted: 3 Feb 2020
Last updated: 22 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluating the Therapeutic Efficacy of Rifaximin in Patients With Diabetic Gastroparesis Using Bloating as the Primary Endpoint.
ClinicalTrials.gov ID: NCT04254549
Acronym / sponsor ID: 19-002908
Conditions: Crohn Disease, Diabetic Gastroparesis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor discontinued placebo. Unable to meet enrollment goals.
Enrolment: 5 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 14 Jun 2019 (actual)
Primary completion: 8 Apr 2025 (actual)
Study completion: 11 Apr 2025 (actual)
First posted: 5 Feb 2020 (actual)
Results: Posted 22 Jun 2026

Clinical summary

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

Researchers are trying to determine if subjects with diabetic gastroparesis and symptoms of bloating will have a greater improvement in bloating symptoms when treated with rifaximin.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Intervention Treatment	Experimental	Drug: RifaximinSubjects diagnosed with gastroparesis will receive Rifaximin
Placebo Group	Placebo comparator	Drug: PlaceboSubjects diagnosed with gastroparesis will receive a placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men and women adult patients, aged 18-75, with diabetic gastroparesis
Diagnosis of diabetic gastroparesis will have been made previously using a combination of symptoms (e.g., nausea, vomiting, bloating, early satiety, abdominal pain), the absence of mechanical obstruction, and delayed gastric emptying using a 4-hour, solid phase scintigraphic study (GES; > 20% remaining at 4 hours)

Key exclusion criteria (9 listed)

Prior surgery to the stomach or esophagus
Known mechanical obstruction of the GI tract
Current or recent (< 4 weeks) use of opioids
Current/active use of cannabis
Current or recent (< 4 weeks) use of antibiotics

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
RifaximinAlso: TD-1473550 mg by mouth three times daily for 14 days	Drug	Intervention Treatment
PlaceboBy mouth three times daily for 14 days	Drug	Placebo Group

Primary outcome

Improvement in Bloating Based on Overall Questionnaire Scoring
Time frame: From enrollment to end of treatment at 8 weeks.
Change is the self reported bloating questionnaire comprised of 45 questions addressing symptoms of bloating/distention. Questionnaires used are the Quality of Life SF-36v2 Survey, Gastroparesis Cardinal Symptom Index Daily Diary, Hospital Anxiety and Depression Scale, and Nepean Dyspepsia Index.

Results and safety

Results posted to the registry on 22 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Treatment	4	4
Placebo Group	1	1

Primary outcome: Improvement in Bloating Based on Overall Questionnaire Scoring

Time frame: From enrollment to end of treatment at 8 weeks.. Number. Unit: participants

Measure	Intervention Treatment n = 4	Placebo Group n = 1
Value	4	1

Adverse events

Time frame: From enrollment to the end of the 8 week study or patient early withdrawal.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Treatment	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Placebo Group	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): Some limitations included finding patients who were the correct diagnosis and without any exclusion criteria. Due to needing medication, patients also needed to be able to come to clinic if they were not local to Jacksonville. This caused some limitations on which patients were willing to make the journey.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Crohn Disease

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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.

Brian E Lacy principal investigator

Mayo Clinic

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rifaximin in people with Crohn Disease and Diabetic Gastroparesis, run by Mayo Clinic 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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 Jun 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Improvement in Bloating Based on Overall Questionnaire Scoring (time frame: From enrollment to end of treatment at 8 weeks.). 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 NCT04254549.

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 22 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.