The Effects of Butyrate Enemas on Visceral Perception

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Visceral (Hyper)Sensitivity

Treatments: Drug: Butyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT00726817

MEC 06-3-020

Details and patient eligibility

About

During this double blind, placebo controlled, randomised cross over study, healthy volunteers received an enema once daily for one week containing either placebo (saline), 50mM butyrate or 100mM of butyrate. Before and directly after each test period a barostat protocol was performed to measure parameters for visceral perception.

Enrollment: 11 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy

Exclusion criteria

• age, under 18 or over 65
• use of pre- or probiotics during study and 3 months previous to study
• previous bowel complaints
• gastrointestinal disease or abdominal surgery

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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11 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

enemas, once daily, containing saline

Treatment:

Drug: Butyrate

2

Experimental group

Description:

enemas, once daily, containing 50mM butyrate

Treatment:

Drug: Butyrate

3

Experimental group

Description:

enemas, once daily, containing 100mM butyrate

Treatment:

Drug: Butyrate