The Effects of a Ficus Carica in Subjects With Functional Constipation

Phase 2

Completed

• Conditions: Functional Constipation
• Interventions: Dietary Supplement: Placebo (300g/day); Dietary Supplement: Ficus Carica (300g/day)

• Registration Number: NCT02138851
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Fig paste on functional constipation. The investigators measured colon transit time, frequency of defecation, defecation time, stool type, and abdominal discomfort.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-13
• Study First Posted: 2014-05-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• age between 19 and 39 years,
• diagnosis of functional constipation by ROME III criteria,
• Colon transit time (CTT) ≥ 36 h,
• subjects giving written informed consent

Exclusion Criteria

• allergic or hypersensitive response to any of the ingredients in the test products,
• having previous history or current disease of digestive system, cardiovascular system, endocrine system and neurological disorder,
• diagnosis of irritable bowel syndrome by ROME III criteria, etc,.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (300g/day)	Placebo 300g/day
Ficus Carica	Ficus Carica (300g/day)	Ficus Carica 300g/day

Primary Outcome Measures

Name	Time	Method
Changes in colon transit time	8 weeks	Colon transit time was measured in study baseline and visit 3(8 week). Colonic transit time was measured by the method of Metcalf et al,. Subjects ingested a once-daily series of three distinctive ColomarkTM capsules at the same time each day for three consecutive days. Each capsule contained twenty radioopaque makers of a ring shape. Subjects then received abdominal X-rays 24 after the ingestion of the final capsule. Abdominal X-rays through a Number of markers present was confirmed. The CTT was calculated as the sum of the markers detected on X-ray.

Secondary Outcome Measures

Name	Time	Method
Changes in frequency of defecation	8 week	Frequency of defecationI was measured in study baseline and visit 3(8 week).
Changes in defecation time	8 week	Defecation time was measured in study baseline and visit 3(8 week).
Changes in stool type	8 week	Stool type was measured in study baseline and visit 3(8 week). Stool type is composed as follows: Separate hard lumps, like nuts. (score 1); Sausage-shaped but lumpy (score 2); Like a sausage or snake but with cracks on its surface (score 3); Like a sausage or snake, smooth and soft. (score 4); Soft blobs with clear-cut edges (score 5); Fluffy pieces with ragged edges, a mushy stool (score 6); Watery, no solid pieces (score 7). The average score is closer to the three-point mode means a normal stool.
Changes in abdominal discomfort	8 week	Abdominal discomfort was measured in study baseline and visit 3(8 week). Abdominal discomfort each question is composed as follows: Very poor (score 1); Poor (score 2); Average (score 3); Good (score 4); Very good (score 5). A higher score means severe abdominal pain.

Trial Locations

Locations (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital; 🇰🇷 Jeonju, Jeollabuk-do, Korea, Republic of