The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

N

National Nutrition and Food Technology Institute

Status

Enrolling

Conditions

Primary Sclerosing Cholangitis
Ulcerative Colitis

Treatments

Dietary Supplement: Bromlein
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT06351696
43008563

Details and patient eligibility

About

In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks. IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention.

Enrollment

84 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • active mild to moderate UC
  • no other chronic disorders

Exclusion criteria

  • changed the type and dosage of their medication in the last month
  • those who have relapses that required hospitalization and change the type and dosage of medications during the intervention
  • patients who do not want to continue the study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

84 participants in 2 patient groups, including a placebo group

Intervention
Active Comparator group
Description:
Bromleine
Treatment:
Dietary Supplement: Bromlein
Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Azita Hekmatdoost, MD, PhD; Reihaneh Samieeian, MSc

Data sourced from clinicaltrials.gov

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