UMIN-CTR Clinical Trial

Basic information
Public title	Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Acronym	Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Scientific Title	Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Scientific Title:Acronym	Correlation between capsule endoscopy and fecal calprotectin levels in small bowel lesions of Crohn's disease
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the correlation between capsule endoscopy and fecal calprotectin in small bowel Crohn's disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between Lewis score of small bowel capsule endoscopy and fecal calprotectin
Key secondary outcomes	1. Correlation between fecal calprotectin and Alb, CRP, or ESR 2. Correlation between fecal calprotectin and HBI 3. Correlation between fecal calprotectin and CECDAI 4. Cleansing level of small bowel capsule endoscopy

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients adapted for small bowel capsule endoscopy 2. Patients confirmed diagnosis of Crohn's disease 3. Patients who are confirmed patency by patency capsule 4. Patients with Ileal, Ileocollic, or aphthous-type Crohn's disease 5. Patients without history of abdominal surgery
Key exclusion criteria	1. Patients with malignant tumor 2. Patients with acute abdomen 3. Patients with serious acute inflammation 4. Patients with pregnant woman 5. Patients who cannot be confirmed GI patency under patency capsule 6. Patient's general health is extremely poor, Patients who has risk for performing endoscopy such as ileus, perforation, pancreatitis, respiratory disorder, cardiovascular disorder, acquired hemophilia, stenosis, large ulcer, or tumor 7. Patients with active lesions in colon 8. Patients with stoma 9. Patients with history of abdominal surgery 10. Patients with habitual NSAIDs consumption 11. Colonic Crohn's disease 12. Patients used to participate in this trial 13. Also, patients who are judged not suitable for this trial by the doctor
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Teruyuki Middle name Last name Takeda
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Zip code	8188502
Address	1-1-1 Zokumyoin Chikushino Fukuoka, Japan
TEL	092-921-1011
Email	take5times@hotmail.co.jp

Public contact
Name of contact person	1st name Teruyuki Middle name Last name Takeda
Organization	Fukuoka University Chikushi Hospital
Division name	Department of Gastroenterology
Zip code	8188502
Address	1-1-1 Zokumyoin Chikushino Fukuoka, Japan
TEL	092-921-1011
Homepage URL
Email	take5times@hotmail.co.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization	Fukuoka University Chikushi Hospital, Sanyo Chemical Industries, Ltd.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Fukuoka University Chikushi Hospital
Address	1-1-1 Zokumyoin, Chikushino City, Fukuoka, Japan
Tel	092-921-1011
Email	chikushirinsho@adm.fukuoka-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	福岡大学筑紫病院（福岡県）、久留米大学病院（福岡県）、九州大学病院（福岡県）、芦屋中央病院（福岡県）、戸畑共立病院（福岡県）、佐賀大学医学部付属病院（佐賀県）、長崎大学病院（長崎県）、熊本大学病院（熊本県）、宮崎大学医学部付属病院（宮崎県）、鹿児島大学病院（鹿児島県）、鮫島病院（鹿児島県）、琉球大学医学部付属病院（沖縄県）、浦添総合病院（沖縄県）

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2019 Year 02 Month 01 Day
Date of IRB	2019 Year 05 Month 15 Day
Anticipated trial start date	2019 Year 04 Month 21 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We perform Capsule endoscopy, Colonoscopy, and Fecal Calprotectine.

Management information
Registered date	2019 Year 03 Month 27 Day
Last modified on	2019 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040827