Trial Outcomes & Findings for Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova (NCT NCT01433471)

NCT ID: NCT01433471

Last Updated: 2016-07-01

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Baseline, 12 weeks, 24 weeks

Results posted on

2016-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Trichuris Suis Ova Followed by Placebo Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks	Placebo Followed by Trichuris Suis Ova Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks
Overall Study STARTED	2	2
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Trichuris Suis Ova Followed by Placebo Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks	Placebo Followed by Trichuris Suis Ova Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trichuris Suis Ova Followed by Placebo n=2 Participants Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks	Placebo Followed by Trichuris Suis Ova n=2 Participants Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 12 weeks, 24 weeks

Population: Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.

To assess ulcerative colitis disease activity

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks

Population: Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned. Therefore, no outcome measure data is available.

To assess ulcerative colitis disease activity without requiring endoscopy

Outcome measures

Outcome data not reported

Adverse Events

Trichuris Suis Ova

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Trichuris Suis Ova n=3 participants at risk	Placebo n=4 participants at risk
General disorders Abdominal pain	100.0% 3/3 • Number of events 4	75.0% 3/4 • Number of events 3
General disorders Abdominal fullness	66.7% 2/3 • Number of events 2	50.0% 2/4 • Number of events 2
Gastrointestinal disorders Excess flatulence	66.7% 2/3 • Number of events 2	50.0% 2/4 • Number of events 2
Gastrointestinal disorders Diarrhea	66.7% 2/3 • Number of events 2	75.0% 3/4 • Number of events 3
Gastrointestinal disorders Perianal pruritis	33.3% 1/3 • Number of events 2	50.0% 2/4 • Number of events 5
General disorders Fatigue	66.7% 2/3 • Number of events 2	50.0% 2/4 • Number of events 2
Gastrointestinal disorders Nausea/Vomiting	33.3% 1/3 • Number of events 1	25.0% 1/4 • Number of events 1
Infections and infestations Clostridium difficile infection	33.3% 1/3 • Number of events 1	0.00% 0/4
Investigations Increase in ALT	0.00% 0/3	25.0% 1/4 • Number of events 1

Additional Information

Martin Wolff

NYU Langone Medical Center

Phone: (646) 329-7259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place