The Effects of a Ficus Carica in Subjects With Functional Constipation

• ClinicalTrials.gov Identifier: NCT02138851
• Recruitment Status: Completed
• First Posted: May 15, 2014
• Last Update Posted: May 16, 2016
• Sponsor: Chonbuk National University Hospital
• Information provided by (Responsible Party): Soo-Wan Chae, Chonbuk National University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Functional Constipation	Dietary Supplement: Ficus Carica (300g/day); Dietary Supplement: Placebo (300g/day)	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Subjects With Functional Constipation, to Evaluate the Improvement in Constipation of Ficus Carica
• Study Start Date: June 2013
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ficus Carica; Ficus Carica 300g/day	Dietary Supplement: Ficus Carica (300g/day); Ficus Carica (300g/day), parallel design
Placebo Comparator: Placebo; Placebo 300g/day	Dietary Supplement: Placebo (300g/day); Placebo (300g/day), parallel design

Outcome Measures

Primary Outcome Measures :

1. Changes in colon transit time [ Time Frame: 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 :

1. Changes in frequency of defecation [ Time Frame: 8 week ]
   Frequency of defecationI was measured in study baseline and visit 3(8 week).
2. Changes in defecation time [ Time Frame: 8 week ]
   Defecation time was measured in study baseline and visit 3(8 week).
3. Changes in stool type [ Time Frame: 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.
4. Changes in abdominal discomfort [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 39 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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,.

Contacts and Locations

Locations

Korea, Republic of

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, Korea, Republic of, 561-712

Sponsors and Collaborators

Chonbuk National University Hospital

More Information

• Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT02138851
• Other Study ID Numbers: YGF-CON-FIG2
• First Posted: May 15, 2014
• Last Update Posted: May 16, 2016
• Last Verified: May 2016

Additional relevant MeSH terms:

Constipation; Signs and Symptoms, Digestive