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Trial Outcomes & Findings for Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis (NCT NCT00751933)

NCT ID: NCT00751933

Last Updated: 2015-04-28

Results Overview

No patient completed the study, therefore we have no information to report.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

6 months

Results posted on

2015-04-28

Participant Flow

Participant milestones

Participant milestones
Measure
Vaccine Arm 2
Vaccination with Vivotif and Dukoral Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.
Oats Supplement 3
Dietary supplement with oats Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Placebo 4
Placebo instead of vaccines No dietary supplement Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
Vaccine and Oats 1
Vaccination with Vivotif and Dukoral + dietary supplement with oats. Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14. One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Overall Study
STARTED
0
1
1
1
Overall Study
COMPLETED
0
0
0
0
Overall Study
NOT COMPLETED
0
1
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Vaccine Arm 2
Vaccination with Vivotif and Dukoral Vaccine Vivotif + Vaccine Dukoral: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14.
Oats Supplement 3
Dietary supplement with oats Oats: One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Placebo 4
Placebo instead of vaccines No dietary supplement Placebo: Placebo capsules instead of Vivotif capsules Placebo mixture instead of liquid Dukoral vaccine
Vaccine and Oats 1
Vaccination with Vivotif and Dukoral + dietary supplement with oats. Vaccine Vivotif + Vaccine Dukoral + oats: Vivotif 1 capsule at study day 1,3,5 and 7. Dukoral oral mixture taken with sodium hydrogen carbonate in water at study day 1 and 14. One daily portion of oats porridge made from oats grain 1dL and water, 6 days a week for 6 months.
Overall Study
Withdrawal by Subject
0
1
0
0
Overall Study
Physician Decision
0
0
1
1

Baseline Characteristics

Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Arms
n=3 Participants
Three patients entered the study, one man, two women. Age 24-41 years. The study was terminated due to lack of patients for inclusion.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=99 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
Age, Continuous
32 years
n=99 Participants
Sex: Female, Male
Female
2 Participants
n=99 Participants
Sex: Female, Male
Male
1 Participants
n=99 Participants
Region of Enrollment
Norway
3 participants
n=99 Participants

PRIMARY outcome

Timeframe: 6 months

No patient completed the study, therefore we have no information to report.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

No patient completed the study, therefore we have no information to report.

Outcome measures

Outcome data not reported

Adverse Events

All Arms

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gunnar Nysæter or Solomon Tefera or Jan Hatlebakk

Haukeland University Hospital

Phone: +47 55972900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place