Status:
UNKNOWN
Evaluation of a Supplement of Agave Tequilana Weber Azul vs Psyllium Plantago in Patients With Functional Constipation
Lead Sponsor:
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Conditions:
Functional Constipation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Introduction: Constipation is one of the gastrointestinal disorders MOST frequent That Affects around 20% of the western population, being more frequent in the female gender (M1.5: H1). Constipation c...
Detailed Description
This is a prospective, randomized, controlled and single blind study to determine the phase III efficacy of the blue agave fructans Tequilana Weber intake in subjects with functional constipation. In...
Eligibility Criteria
Inclusion
- Patients over 18 years old.
- functional constipation ROME III criteria as
- Subjects ≥55 years with recent colonoscopy (\<3 years)
Exclusion
- Taking supplements of fiber in the last 2 months
- Stimulant laxatives consumption chronically (Senna, Bisacodyl)
- decompensated comorbidities (example: uncontrolled diabetes mellitus HbA1c\> 9%, decompensated Organ failure, decompensated hypertension (untreated or TA\> 160 mmHg systolic and 95 mmHg diastolic)
- Using digital maneuvers or enemas to achieve evacuation
- Personal history of active or previous cancer
- abdominal surgery (except appendectomy, cholecystectomy, hysterectomy)
- Presence of alarm data in the last 6 months (trans-rectal bleeding, unexplained weight loss, abdominal pain)
- Use of drugs known promote constipation (opioid derivatives, calcium channel blockers, anticholinergics tricyclic antidepressants type)
- Prostration (immobility or poor mobility)
- Diseases such as untreated hypothyroidism with hormone replacement, and diseases associated with hypercalcemia that promote constipation
- Other causes of secondary constipation
- Meet criteria for constipation predominant irritable bowel
- Pregnancy.
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 18 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04716868
Start Date
July 18 2019
End Date
August 18 2021
Last Update
February 17 2021
Active Locations (1)
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1
National Institute of Medical Sciences and Nutrition Salvador Zubiran
Mexico City, Mexico City, Mexico, 14080