Condition category
Digestive System
Date applied
13/01/2011
Date assigned
16/02/2011
Last edited
16/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luis Maria Bustos Fernandez

ORCID ID

Contact details

Echeverria 2771
CABA
1428
Argentina
lbustos@arnetbiz.com.ar

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A controlled pilot study on the efficacy of a high fibre diet and a low dose lincomycin for chronic constipation

Acronym

Study hypothesis

Assess the synergistic short term, low dose, preparatory action of a poorly absorbable antibiotic on chronic constipated patients on a high fibre diet.

Ethics approval

This was a very small pilot observational study started in 1996 and finalised 1 year later. At the time of this pilot study, there was an exogenous improvised board named simply by the principal investigator and the ethics board that met gave only verbal approval. Since then, this board has dissolved and unfortunately records are not available.

Study design

Randomised double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Chronic constipation

Intervention

The study design determined a 15-day run-in phase without any drug or rescue laxatives and a 21-day controlled treatment period. On the first day of the controlled treatments period (Day 0) enrolled patients were randomised to an initial 10 day low dose lincomycin (0.5 g/d) or to placebo. During the 21 day treatment period, the diet of all patients was supplemented by 12 g of crude fibre (All Bran Kellog).

Patients were assigned a number on accordance to a validated 10 point Visual Analogue Scale (VAS) of symptom severity (0 = very severe, 10 = asymptomatic). Post-hoc, we examined the proportion of patients that exhibited marked improvement in the efficacy parameters after the 21 day treatments.

Intervention type

Drug

Phase

Not Applicable

Drug names

Lincomycin

Primary outcome measures

Difference between treatments in the mean bowel frequency, straining, stool consistency and pain during defecation at baseline (Day 0) and by the end of treatment period (Day 21).

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/09/1996

Overall trial end date

15/04/1997

Reason abandoned

Eligibility

Participant inclusion criteria

1. Meet Rome II diagnostic criteria for chronic constipation characterised by:
1.1. A frequency of less than or equal to two bowel movements/week
1.2. Hard stool
1.3. Straining with occasional pain in more than 25% of bowel movements
2. Aged over 18 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients

Participant exclusion criteria

1. Cardiac, pulmonary, renal, liver failure
2. Abnormal blood chemistries
3. Known antibiotic allergies

In patients who were younger than 50 years and had no other complaint than chronic constipation and the physical examination and routine body chemistries were normal, it was assumed the diagnostic of functional constipation and no special gastrointestinal exams were performed. Patients greater than or equal to 50 years or with lower gastrointestinal bleeding underwent colon radiology or colonoscopy to rule out organic colorectal disease.

Recruitment start date

05/09/1996

Recruitment end date

15/04/1997

Locations

Countries of recruitment

Argentina

Trial participating centre

Echeverria 2771
CABA
1428
Argentina

Sponsor information

Organisation

Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)

Sponsor details

Echeverria 2771
CABA
1428
Argentina
lbusto@arnetbiz.com.ar

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Institute of Gastroenterology (Instituto de Gastroenterologia) (Argentina)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes