Elobixibat Research on Stool Bile Acid in Patients With Chronic Constipation

JRCT ID: jRCTs031180035

Registered date:31/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 06/12/2018
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Patients with chronic constipation group Elobixibat 10 mg will be administered about 30 minutes before breakfast once daily for 7 days.
Healthy volunteer group Healthy volunteers will not receive elobixibat

Outcome(s)

• Primary Outcome: Changes in the amount of bile acids in the stool after the completion of treatment with elobixibat from the baseline in patients with chronic constipation

Secondary Outcome

-Comparison of the amount of bile acids and bile acid fractions in the stool, bile acid concentrations and bile acid fractions in the blood, C4 and FGF19 concentrations in the blood during the baseline period in patients with chronic constipation with that in the stool in healthy adult volunteers.

-Comparison of bile acid fractions in the stool, bile acid concentrations and bile acid fractions in the blood, C4 and FGF19 concentrations in the blood during the baseline period in patients with chronic constipation with or without elobixibat administration.

-Relationship of bile acid concentrations and bile acid fractions in the stool, bile acid concentrations and bile acid fractions in the blood, C4 and FGF19 concentrations in the blood with pharmacological evaluation index (stool form, stool weight, water content in the stool, frequency of bowel movements, time to Spontaneous Bowel Movement, straining, and defecation desire, etc.)

-Stool form, stool weight, water content in the stool, frequency of bowel movements, sensation of incomplete evacuation, Time from administration to Spontaneous Bowel Movement, straining, and defecation desire, etc.

-Comparison of bile acid concentrations in each defecation (spot stool) with those in 48-hour stool collected.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hasunuma Tomoko
• Secondary Sponsor: EA Pharma Co.,Ltd.