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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047319
Receipt No. R000053973
Scientific Title Wheat bran enema as adjuvant therapy in infants with Lower respiratory tract infection
Date of disclosure of the study information 2022/04/01
Last modified on 2022/03/30

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Basic information
Public title Wheat bran enema as adjuvant therapy in infants with Lower respiratory tract infection
Acronym Wheat bran enema in infants with Lower respiratory tract infection
Scientific Title Wheat bran enema as adjuvant therapy in infants with Lower respiratory tract infection
Scientific Title:Acronym Wheat bran enema in infants with Lower respiratory tract infection
Region
Africa

Condition
Condition Lower respiratory tract infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the impact of wheat bran enema as adjuvant therapy on oxidative stress and inflammatory and anti-inflammatory cytokine in the pediatric patients with lower RTI.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigate the impact of wheat bran enema as adjuvant therapy on oxidative stress and inflammatory and anti-inflammatory cytokine in paediatric patient with lower RTI.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 the first group includes 20 patients who will receive conventional treatment only
Interventions/Control_2 The second group includes 20 patients who will receive conventional treatment and wheat bran enema
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
1 months-old <=
Age-upper limit
3 years-old >=
Gender Male and Female
Key inclusion criteria Patients>1 month and up to 3 years, diagnosed with lower respiratory tract infection admitted to Children Hospital, Faculty of Medicine, Assiut University during the study period
Key exclusion criteria Patients age less than one month and more than three years
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Khaled
Middle name
Last name Saad
Organization Assiut University
Division name Pediatric department
Zip code 71515
Address Assiut University
TEL +20882368373
Email khaled.ali@med.au.edu.eg

Public contact
Name of contact person
1st name Khaled
Middle name
Last name Saad
Organization Assiut University
Division name Pediatric department
Zip code 71515
Address Assiut University
TEL +20882368373
Homepage URL
Email khaled.ali@med.au.edu.eg

Sponsor
Institute Assiut university
Asyut Egypt
Institute
Department

Funding Source
Organization Assiut university
Asyut Egypt
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Egyptian

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

IRB Contact (For public release)
Organization Assiut university Asyut Egypt
Address Assiut university Asyut Egypt
Tel +20882368373
Email Asmaa.zahran@aun.edu.eg

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

Other administrative information
Date of disclosure of the study information
2022 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2022 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 04 Month 15 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 03 Month 30 Day
Last modified on
2022 Year 03 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053973

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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