Are probiotics beneficial for ulcerative colitis patients with poor pelvic pouch function?

Effect of probiotics (Lactobacillus plantarum 299® plus Bifidobacterium Cure 21®) or placebo on the pouch bacterial flora and immunological response patterns in poor pelvic pouch function: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN50513887

Enrollment

Registered

2009-02-16

Start date

2006-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis Digestive System Ulcerative colitis

Interventions

Participants are randomly allocated to the following two arms (randomisation ratio 1:1). Intervention group: Probiotics (Lactobacillus plantarum 299® [5 x 10^9 cfu] plus Bifidobacterium Cure 21® [5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, age 18-75 years 2. Patient with a pelvic pouch because of ulcerative colitis. The pouch function should be inferior according to a clinical evaluation including a pouch function score.

Exclusion criteria

Exclusion criteria: 1. Patient with a pelvic pouch, but with other diagnoses, e.g., Crohn's disease or polyposis 2. Patients with good pouch function

Design outcomes

Primary

Measure	Time frame
The following will be assessed at baseline and end of treatment (3 weeks): 1. Types of bacterial species in the pelvic pouch, analysed by non-culture dependent techniques, such as Terminal-Restriction Fragment Length Polymorphism (T-RFLP) 2. Markers of mucosal inflammation in faeces: calprotectin, lactoferrin, myeloperoxidase (MPO) and eosinophil cationic protein (ECP) 3. Inflammation of the lining of the rectum and colon, assessed by biopsies 4. Immunological response patterns, assessed by examination of leukocytes in blood samples	—

Measure

Time frame

The following will be assessed at baseline and end of treatment (3 weeks): 1. Types of bacterial species in the pelvic pouch, analysed by non-culture dependent techniques, such as Terminal-Restriction Fragment Length Polymorphism (T-RFLP) 2. Markers of mucosal inflammation in faeces: calprotectin, lactoferrin, myeloperoxidase (MPO) and eosinophil cationic protein (ECP) 3. Inflammation of the lining of the rectum and colon, assessed by biopsies 4. Immunological response patterns, assessed by examination of leukocytes in blood samples

—

Secondary

Measure	Time frame
1. Clinical pouch function is evaluated by a questionnaire before and within 3 days from the end of treatment 2. Pouch biopsies are evaluated by standard histopathology before and within 3 days from the end of treatment	—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026