Active — Not RecruitingPhase 1/2

Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease

United States30 participantsStarted 2019-05-01

Plain-language summary

This study will evaluate the safety of oral administration of EcoActive to patients with inactive Crohn's disease and how it affects the levels of AIEC in stool.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female ≥ 18 years of age
. Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) \< 4
. Permitted CD medications expected to remain stable during the period of the study (see Section 7 "Concomitant Crohn's Disease Medications" for allowed and prohibited drugs).
. Crohn's disease history ≥ 6-month duration
. CRP (C-reactive protein) within normal range at the Screening visit (based on normal range of the local laboratory)
. Fecal calprotectin level ≤ 150 µg/g at the Screening visit
. AIEC detected in the stool
. Females of childbearing age must be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).

Exclusion criteria

. Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events

Timeframe: Up to 6 months

Severity of adverse events

Timeframe: Up to 6 months

Effect on Harvey Bradshaw Index (HBI)

Timeframe: Up to 6 months

Effect on inflammation, as indicated by C-reactive protein (CRP)

Timeframe: Up to 6 months

Effect on inflammation, as indicated by fecal calprotectin

Timeframe: Up to 6 months

Trial details

NCT IDNCT03808103

SponsorIntralytix, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-01

View on ClinicalTrials.gov More Crohn Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female ≥ 18 years of age
. Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) \< 4
. Permitted CD medications expected to remain stable during the period of the study (see Section 7 "Concomitant Crohn's Disease Medications" for allowed and prohibited drugs).
. Crohn's disease history ≥ 6-month duration
. CRP (C-reactive protein) within normal range at the Screening visit (based on normal range of the local laboratory)
. Fecal calprotectin level ≤ 150 µg/g at the Screening visit
. AIEC detected in the stool
. Females of childbearing age must be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).

Exclusion criteria

. Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4

What they're measuring

Incidence of adverse events

Timeframe: Up to 6 months

Severity of adverse events

Timeframe: Up to 6 months

Effect on Harvey Bradshaw Index (HBI)

Timeframe: Up to 6 months

Effect on inflammation, as indicated by C-reactive protein (CRP)

Timeframe: Up to 6 months

Effect on inflammation, as indicated by fecal calprotectin

Timeframe: Up to 6 months