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