Inflammatory Bowel DiseasesNCT03445624
Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
Trial summary
assessment of inflammatory bowel disease patients in activity and remission by abdominal ultrasound examine non-invasive and in physiological condition by measuring the colon wall thickness in diagnosis and follow up the patient also including extra intestinal features such as the splanchnic vessels,mesentery and… Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Infliximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Oct 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all patients diagnosed inflammatory bowel disease (ulcerative colitis and crohns disease) at age(15 -60)
Who may be able to join
- patients diagnosed ulcerative colitis at age(15-60)
- patients diagnosed crohns disease at age(15-60)k
Who cannot join
- liver cirrhosis and portal hypertension
- spontaneous bacterial peritonitis
- Ischemic colitis
Trial locations and contacts
1 site in 1 country.
About this study
assessment of inflammatory bowel disease patients in activity and remission by abdominal ultrasound examine non-invasive and in physiological condition by measuring the colon wall thickness in diagnosis and follow up the patient also including extra intestinal features such as the splanchnic vessels,mesentery and lymph nodes . Doppler u.s can evaluate bowel wall vascularity In activity and remission . peripheral hemogram in relationship to activity inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume( MPV) . also,the investigator will evaluate the outcome of different lines of treatment traditional and biologic therapy (response to treatment,times of activity and complications)
Read the detailed description
the participants will follow up the patient for 1 year in the first visit
All patients in this study will be subjected to:
- Detailed history.
- Careful physical examination
- laboratory investigation
- complete blood picture.
- liver function
- kidney function
- Iron profile(serum iron ,serum ferritin
- ESR (erythrocyte sedimentation rate ) g-CRP (C reactive protein) f-LDH (lactate dehydrogenase)
- Abdominal us(the colon wall thickness,lymph nodes,mass,other organs)
- Doppler us (mesenteric vessels)
- colonoscopy after 1 year of treatment follow up every 3 months by abdominal US and peripheral hemogram and last visit after 1 year colonoscopy and biopsy for assessment response to treatment
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Infliximab
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called steroid,immuran 5ASA
follow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| patient on traditional therapy | Drug: steroid,5ASA , immuran for assesment the outcome of therapy in inflammatory bowel disease steroid(40- 60mg tablet),5ASA(pentasa 3-4gm tablet),azathioprin (immuran 100 mg tablet) Receives: Drug: Infliximab | |
| patient on infliximab | drug : infliximab (5mglkg intravenous)for the first dose,the second dose after 2 weeks the third dose after 6 weeks then every 2 months Receives: Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the role abdominal ultrasound in assessment inflammatory bowel disease
measure the thickness of the colon by abdominal ultrasound and doppler mesenteric vessels .more than 4ml detect activity doppler mesenteric highly vascularity in activity
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start1 Jul 2018
- Primary completion1 Feb 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hyam fathy, Assiut University
- Investigators
- ahmed ashmawy, Study director, lecturer of internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445624
- Sponsor's protocol ID
- assiut hospitals university
- Status last verified
- Jul 2020
- First submitted
- 9 Jan 2018
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Ultrasound With Doppler and Peripheral Hemogram in Assesment Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03445624
- Acronym / sponsor ID
- assiut hospitals university
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
assessment of inflammatory bowel disease patients in activity and remission by abdominal ultrasound examine non-invasive and in physiological condition by measuring the colon wall thickness in diagnosis and follow up the patient also including extra intestinal features such as the splanchnic vessels,mesentery and lymph nodes . Doppler u.s can evaluate bowel wall vascularity In activity and remission . peripheral hemogram in relationship to activity inflammatory bowel disease asses anemia ,increase monocyte and decrease mean platelet volume( MPV) . also,the investigator will evaluate the outcome of different lines of treatment traditional and biologic therapy (response to treatment,times of activity and complications)
Detailed description
the participants will follow up the patient for 1 year in the first visit
All patients in this study will be subjected to:
- Detailed history.
- Careful physical examination
- laboratory investigation
- complete blood picture.
- liver function
- kidney function
- Iron profile(serum iron ,serum ferritin
- ESR (erythrocyte sedimentation rate ) g-CRP (C reactive protein) f-LDH (lactate dehydrogenase)
- Abdominal us(the colon wall thickness,lymph nodes,mass,other organs)
- Doppler us (mesenteric vessels)
- colonoscopy after 1 year of treatment follow up every 3 months by abdominal US and peripheral hemogram and last visit after 1 year colonoscopy and biopsy for assessment response to treatment
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient on traditional therapy | – | Drug: InfliximabDrug: steroid,5ASA , immuran for assesment the outcome of therapy in inflammatory bowel disease steroid(40- 60mg tablet),5ASA(pentasa 3-4gm tablet),azathioprin (immuran 100 mg tablet) |
| patient on infliximab | – | Drug: Infliximabdrug : infliximab (5mglkg intravenous)for the first dose,the second dose after 2 weeks the third dose after 6 weeks then every 2 months |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all patients diagnosed inflammatory bowel disease (ulcerative colitis and crohns disease) at age(15 -60)
Key inclusion criteria (2 listed)
- patients diagnosed ulcerative colitis at age(15-60)
- patients diagnosed crohns disease at age(15-60)k
Key exclusion criteria (3 listed)
- liver cirrhosis and portal hypertension
- spontaneous bacterial peritonitis
- Ischemic colitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InfliximabAlso: steroid,immuran 5ASAfollow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy | Drug | patient on infliximab, patient on traditional therapy |
Primary outcome
the role abdominal ultrasound in assessment inflammatory bowel disease
Time frame: 2 year
measure the thickness of the colon by abdominal ultrasound and doppler mesenteric vessels .more than 4ml detect activity doppler mesenteric highly vascularity in activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed ashmawy study director
lecturer of internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the role abdominal ultrasound in assessment inflammatory bowel disease (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.