Comparison of GI tract pH and motility between patients with ulcerative colitis and healthy controls

JRCT ID: jRCTs052210199

Registered date:22/03/2022

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Ulcerative colitis
• Date of first enrollment: 22/03/2022
• Target sample size: 25
• Study type: Interventional

Intervention(s)

arm UC
arm Health control
In each case, the SmartPill motility capsule is orally taken with 50 ml of water. The temperature, pH and pressure of the entire digestive tract are measured in real time. Also, the transit time of each of the stomach, small intestine, and large intestine is calculated from the transit time of the capsule.

Outcome(s)

Primary Outcome

Comparison between arm UC and arm Health control in the following items
1 Stomach pH
2 Small intestinal pH
3 Large intestine pH
4 Gastric emptying time (GET)
5 small bowel transit time (SBTT)
6 Colonic traisit time (CTT)

Secondary Outcome

Comparison between arm UC and arm Health control in the following items
1 Stomach pH
2 Small intestinal pH
3 Large intestine pH
4Gastric emptying time (GET)
5 Small bowel transit time (SBTT)
6 Colonic traisit time (CTT)
7 Sites that exceed pH7 for the first time [stomach, small intestine (proximal part), small intestine (middle part), small intestine (distal part), large intestine]

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1. Selection criteria common to UC patients and healthy controls
(1) 20 years old and over, 79 years old or under
(2) Person who can obtain consent by document
2. Selection criteria for UC patients
(1) Patients diagnosed with left-sided colitis-type or total colitis
type UC (10 active and 10 remission)
(2) Treatment content for UC does not matter
Active phase was defined as a SCCAI >=3 and remission was defined as a SCCAI <=2

Exclude criteria

1. Exclusion Criteria Common to UC Patients and Healthy controls
(1) A person with a history of intestinal surgery (excluding appendectomy)
(2)Those who have a history of bowel obstruction
(3) Those with intestinal stricture
(4) Persons whose defecation interval exceeds 48 hours on average
(5) Patients who have difficulty swallowing
(6)Those who have taken drugs that affect intestinal motility (antidiarrheal, laxatives, intestinal motility enhancers, etc.) within 7 days of the start of the test.
(7)Those who have taken drugs (H2 receptor antagonists, proton pump inhibitors, etc.) that affect gastric acid secretion within 7 days of the start of the test
(8) Those who are pregnant or may be pregnant
(9)Those who have judged that it is inappropriate by the investigator to participate in this study
(10) Those with pacemakers

Related Information

• Primary Sponsor: Nakamura Shiro
• Secondary Sponsor: Nishikawa Hiroki