Elobixibat Research on Stool Bile Acid in PatientsWith Chronic Constipatio

Not Applicable

• Conditions: Chronic constipation

• Registration Number: JPRN-jRCTs031180035
• Lead Sponsor: Hasunuma Tomoko

Brief Summary

The amount of total bile acids in stools in patients with chronic constipation was significantly decreased and the proportion of secondary bile acids in the stools was increased in comparison with healthy control. By the administration of elobixibat, the amount of fecal bile acids, especially primary one were significantly increased, and symptoms of constipation were improved. It was suggested that the liver production of the primary bile acids was substituting the excreted primary bile acids in the stools.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-31
• Study Completion: 2019-02-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Patients with chronic constipation
(1)Patients aged >=20 years at the time of informed consent
(2)Patients whose mean Spontaneous Bowel Movement was <3 times/week from at least 6 months prior to informed consent
(3)Patients with one of the following symptoms related to Spontaneous Bowel Movement from at least 6 months prior to informed consent
a.Straining among at least 25% of defecations
b.Scybalum or hard stool among at least 25% of defecations
c.Sensation of incomplete evacuation among at least 25% of defecations
(4)Patients whose Spontaneous Bowel Movement frequency was =<5 times for 14 days prior to admission.(=<2 times for the last week of the 2-week run-in)
(5)Patients whose average Bristol stool form scale was =<3 for the last week of the 2-week run-in
(6)Patients capable of giving written informed consent
Healthy volunteers
(1)Volunteers aged >=20 years at the time of informed consent
(2)Volunteers who have bowel movements almost every day
(3)Volunteers who have no disease requiring routine treatment
(4)Volunteers capable of giving written informed consent

Exclusion Criteria

Patients with chronic constipation
(1)Patients with, or suspected to have, organic constipation, symptomatic constipation or drug-induced constipation
(2)Patients with a medical history of gastrointestinal obstruction
(3)Patients with abdominal hernia
(4)Patients with a surgical history of small or large intestine other than simple appendectomy
(5)Patients with a medical history of surgical or endoscopic intervention related to cholecystectomy and papillotomy
(6)Patients who are proven to be positive for HBs antigen, anti-HCV antibody, serological reaction of syphilis, or anti- HIV-1, 2 antibodies
(7)Patients with current medical history of serious dysfunction related to the kidney (creatinine>=2.00 mg/dL)or the liver (total bilirubin >=3.0 mg/dL or AST or ALT >=100 U/L)
(8)Patients with a history of serious drug-induced allergy
(9)Patients with a past or current medical history of drug poisoning or alcohol poisoning
(10)Pregnant women, lactating women, women with pregnancy suspected
(11)Patients who used the rescue medication within 72 hours after bowel movement during the 2-week screening period
(12)Patients with soft stool or watery stool (Bristol Stool Form Scale type 6 or 7) in Spontaneous Bowel Movement during the 2-week screening period and during the 1-week baseline period
(13)Patients who used the rescue medication more than four times during the 2-week screening period
(14)Patients who used prohibited medications/therapies from the beginning of 2-week screening period to the day of hospitalization
(15)Patients who used the rescue medication during the 1-week baseline period
(16)Patients who were considered as ineligible by the investigator for any other reasons
Healthy volunteers
(1)Volunteers with a medical history of gastrointestinal obstruction
(2)Volunteers with abdominal hernia
(3)Volunteers with a surgical history of small or large intestine other than simple appendectomy
(4)Volunteers who are proven to be positive for HBs antigen, anti-HCV antibody, serological reaction of syphilis, or anti- HIV-1, 2 antibodies
(5)Volunteers with a history of serious drug-induced allergy
(6)Volunteers with a past or current medical history of drug poisoning or alcohol poisoning
(7)Volunteers women, lactating women, women with pregnancy suspected
(8)Volunteers whose mean Spontaneous Bowel Movement was =<3 times/week during the 1-week screening period
(9)Volunteers who used prohibited medications/therapies from the beginning of 1-week screening period to the day of hospitalization
(10)Volunteers who were considered as ineligible by the investigator for any other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified