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 range18 Years

SexALL

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
✕. Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding
✕. Active malignancies or any malignant disease within the past 5 years
✕. Indeterminate colitis, ulcerative colitis
✕. Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis).
✕. Colonic or small bowel stoma
✕. Active perianal lesions
✕. Women who are pregnant or nursing, or plan to become pregnant during the study period

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 range18 Years

SexALL

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
✕. Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding
✕. Active malignancies or any malignant disease within the past 5 years
✕. Indeterminate colitis, ulcerative colitis
✕. Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis).
✕. Colonic or small bowel stoma
✕. Active perianal lesions
✕. Women who are pregnant or nursing, or plan to become pregnant during the study period

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