Ulcerative ColitisNCT04818788
Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Assiut University.
Trial summary
Investigators aimed at investigating the prediction ability of faecal calprotectin to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy Investigators aimed to evaluate the prediction ability of NLR, PLR and MLR to predict mucosal healing and histological… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Biological Drug
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Jun 2022
- 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 18 to 55 years
- All sexes
- Adult
Study population: our study will include ulcerative colitis patients who are indicated to biological therapy at gastro enterology unit in internal medicine department at Assuit university during the period of April 2021 to April 2022 and we will do the following to every patient : full history including drug history full examination colonoscopy and histological examination before the biological therapy and after 8 weeks and after 25 weeks and after 52 weeks ESR , CRP , Fecal calprotectin and CBC including NLR, PLR and MLR before starting biological therapy and after 8 weeks and after 25 weeks and after 52 weeks
Who may be able to join
- 24 patients (males and females at the age between 18 and 55 years) of ulcerative colitis indicated to biological therapy
Who cannot join
- - Ulcerative colitis pregnant women
- Patient receiving biological therapy for extra intestinal manifestation
- Patients on corticosteroids more than 20 mg as it affects leucocytic count
- Patients under the age of 18 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy
Investigators aimed at investigating the prediction ability of faecal calprotectin to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy Investigators aimed to evaluate the prediction ability of NLR, PLR and MLR to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy.
Investigators evaluate the histological remission in ulcerative colitis patients receiving biological therapy in Assuit university hospital.
Read the detailed description
Ulcerative colitis (UC) is a chronic relapsing disease that involves the colorectal mucosa. Over the years, the therapeutic target has been upgraded from the resolution of symptoms to deep remission to prevent relapses and complications. The primary therapeutic target to be achieved in patients with UC is both clinical and endoscopic remission . The assessment of histological inflammation has emerged as a promising endpoint in UC . However, the link between histological disease activity and other measures of clinical disease activity is not yet well established . Some authors suggest that the presence of histological inflammation is a better predictor of future clinical relapse than endoscopic activity . Several studies showed that patients with residual microscopic active inflammation seem to be more prone to relapse when compared with patients with normal histology .
Calprotectin is a 36-kDa calcium- and zinc-binding protein, which represents approximately 60% of soluble proteins of granulocyte cytoplasm . Fecal calprotectin (FC) is strongly correlated with both MES and Ulcerative Colitis Endoscopic Score (9, 10). In previous studies, FC was shown to be helpful in predicting sustained clinical remission and mucosal healing during anti-TNF treatment, particularly with IFX and ADA. However, no investigations have been performed to evaluate the predictive value of FC in terms of mucosal healing in a prospective cohort of patients with UC treated with biological therapy. Based on the above background, the aim of the present prospective study is to identify a reliable biomarker able to predict therapeutic effectiveness in UC .
Ulcerative colitis (UC) is a chronic relapsing disease characterized by a neutrophil-mediated inflammation of the gut.
Indeed, European Crohn and Colitis Organization guidelines have highlighted how the grade of neutrophilic infiltration is necessary for the diagnosis of this pathological condition and for the evaluation of histological activity. Thus, colonoscopy is necessary to collect mucosal biopsies and assess neutrophilic infiltration for the diagnosis and during follow-up to evaluate treatment response and predict long-term outcome, although histological healing is still debated. However, colonoscopy is an invasive, costly, and not always well-tolerated examination for patients. Apart from endoscopic interventions, disease severity can be also assessed using less-invasive biomarkers, including blood count.
In these regard the investigators aimed to investigate the ability of prediction of hematological indices including (PLR, NLR and MLR) and fecal calprotectin to predict histological remission in ulcerative colitis patients receiving biological therapy .
- Conditions
- Ulcerative Colitis
- Being tested
- Biological Drug
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological DrugDrug
we will give biological drugs to indicated ulcerative colitis patients and we will investigate the predictive ability of fecal calprotectin and hematological indices to histological remission
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological remission in ulcerative colitis patients receiving biological therapy
Assessment of histological remission by using Geboes score index Histological remission was defined as Geboes index ≤ 3.0.15 .The Geboes index consists of a scoring system with five distinctive grades [each with subgrades], corresponding to different aspects of inflammatory activity in the mucosa. Grade 0 corresponds to structural [architectural] change, grade 1 to chronic inflammatory infiltrate, grade 2 to lamina propria eosinophils [2A] and neutrophils [2B], grade 3 to neutrophils in the epithelium, grade 4 to crypt destruction, and grade 5 to erosion or ulceration. Higher subgrade scores reflect a more severe condition.
Measured: one year
Assessment of fecal calprotectin level in ulcerative colitis patients receiving biological therapy
measured by quantative enzyme immuno assay μg/g.
Measured: one year
Assessment of the level of PLR, NLR , MLR in ulcerative colitis patients receiving biological therapy
by extraction of the values of blood counts in particular WBC and platelet count
Measured: one year
Ability of hematological indices and fecal calprotectin to predict histological remission
by correlate the level of hematological indices and fecal cal peotectin with histological remission
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion20 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdallah Abdelfadil Abdelal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818788
- Sponsor's protocol ID
- ulcerative colitis
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertani L, Rossari F, Barberio B, Demarzo MG, Tapete G, Albano E, Baiano Svizzero G, Ceccarelli L, Mumolo MG, Brombin C, de Bortoli N, Bellini M, Marchi S, Bodini G, Savarino E, Costa F. Novel Prognostic Biomarkers of Mucosal Healing in Ulcerative Colitis Patients Treated With Anti-TNF: Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio. Inflamm Bowel Dis. 2020 Sep 18;26(10):1579-1587. doi: 10.1093/ibd/izaa062.
PubMed 32232392Magro F, Lopes SI, Lopes J, Portela F, Cotter J, Lopes S, Moreira MJ, Lago P, Peixe P, Albuquerque A, Rodrigues S, Silva MR, Monteiro P, Lopes C, Monteiro L, Macedo G, Veloso L, Camila C, Afonso J, Geboes K, Carneiro F; Portuguese IBD group [GEDII]. Histological Outcomes and Predictive Value of Faecal Markers in Moderately to Severely Active Ulcerative Colitis Patients Receiving Infliximab. J Crohns Colitis. 2016 Dec;10(12):1407-1416. doi: 10.1093/ecco-jcc/jjw112. Epub 2016 May 25.
PubMed 27226417Bertani L, Blandizzi C, Mumolo MG, Ceccarelli L, Albano E, Tapete G, Baiano Svizzero G, Zanzi F, Coppini F, de Bortoli N, Bellini M, Morganti R, Marchi S, Costa F. Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study. Clin Transl Gastroenterol. 2020 May;11(5):e00174. doi: 10.14309/ctg.0000000000000174.
PubMed 32677804Okba AM, Amin MM, Abdelmoaty AS, Ebada HE, Kamel AH, Allam AS, Sobhy OM. Neutrophil/lymphocyte ratio and lymphocyte/monocyte ratio in ulcerative colitis as non-invasive biomarkers of disease activity and severity. Auto Immun Highlights. 2019 May 15;10(1):4. doi: 10.1186/s13317-019-0114-8. eCollection 2019 Dec.
PubMed 32257060
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy
- ClinicalTrials.gov ID
- NCT04818788
- Acronym / sponsor ID
- ulcerative colitis
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 20 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 26 Mar 2021 (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.
Investigators aimed at investigating the prediction ability of faecal calprotectin to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy Investigators aimed to evaluate the prediction ability of NLR, PLR and MLR to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy.
Investigators evaluate the histological remission in ulcerative colitis patients receiving biological therapy in Assuit university hospital.
Detailed description
Ulcerative colitis (UC) is a chronic relapsing disease that involves the colorectal mucosa. Over the years, the therapeutic target has been upgraded from the resolution of symptoms to deep remission to prevent relapses and complications. The primary therapeutic target to be achieved in patients with UC is both clinical and endoscopic remission . The assessment of histological inflammation has emerged as a promising endpoint in UC . However, the link between histological disease activity and other measures of clinical disease activity is not yet well established . Some authors suggest that the presence of histological inflammation is a better predictor of future clinical relapse than endoscopic activity . Several studies showed that patients with residual microscopic active inflammation seem to be more prone to relapse when compared with patients with normal histology .
Calprotectin is a 36-kDa calcium- and zinc-binding protein, which represents approximately 60% of soluble proteins of granulocyte cytoplasm . Fecal calprotectin (FC) is strongly correlated with both MES and Ulcerative Colitis Endoscopic Score (9, 10). In previous studies, FC was shown to be helpful in predicting sustained clinical remission and mucosal healing during anti-TNF treatment, particularly with IFX and ADA. However, no investigations have been performed to evaluate the predictive value of FC in terms of mucosal healing in a prospective cohort of patients with UC treated with biological therapy. Based on the above background, the aim of the present prospective study is to identify a reliable biomarker able to predict therapeutic effectiveness in UC .
Ulcerative colitis (UC) is a chronic relapsing disease characterized by a neutrophil-mediated inflammation of the gut.
Indeed, European Crohn and Colitis Organization guidelines have highlighted how the grade of neutrophilic infiltration is necessary for the diagnosis of this pathological condition and for the evaluation of histological activity. Thus, colonoscopy is necessary to collect mucosal biopsies and assess neutrophilic infiltration for the diagnosis and during follow-up to evaluate treatment response and predict long-term outcome, although histological healing is still debated. However, colonoscopy is an invasive, costly, and not always well-tolerated examination for patients. Apart from endoscopic interventions, disease severity can be also assessed using less-invasive biomarkers, including blood count.
In these regard the investigators aimed to investigate the ability of prediction of hematological indices including (PLR, NLR and MLR) and fecal calprotectin to predict histological remission in ulcerative colitis patients receiving biological therapy .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- our study will include ulcerative colitis patients who are indicated to biological therapy at gastro enterology unit in internal medicine department at Assuit university during the period of April 2021 to April 2022 and we will do the following to every patient : full history including drug history full examination colonoscopy and histological examination before the biological therapy and after 8 weeks and after 25 weeks and after 52 weeks ESR , CRP , Fecal calprotectin and CBC including NLR, PLR and MLR before starting biological therapy and after 8 weeks and after 25 weeks and after 52 weeks
Key inclusion criteria (1 listed)
- 24 patients (males and females at the age between 18 and 55 years) of ulcerative colitis indicated to biological therapy
Key exclusion criteria (4 listed)
- - Ulcerative colitis pregnant women
- Patient receiving biological therapy for extra intestinal manifestation
- Patients on corticosteroids more than 20 mg as it affects leucocytic count
- Patients under the age of 18 years
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 |
|---|---|---|
| Biological Drugwe will give biological drugs to indicated ulcerative colitis patients and we will investigate the predictive ability of fecal calprotectin and hematological indices to histological remission | Drug | – |
Primary outcome
Histological remission in ulcerative colitis patients receiving biological therapy
Time frame: one year
Assessment of histological remission by using Geboes score index Histological remission was defined as Geboes index ≤ 3.0.15 .The Geboes index consists of a scoring system with five distinctive grades [each with subgrades], corresponding to different aspects of inflammatory activity in the mucosa. Grade 0 corresponds to structural [architectural] change, grade 1 to chronic inflammatory infiltrate, grade 2 to lamina propria eosinophils [2A] and neutrophils [2B], grade 3 to neutrophils in the epithelium, grade 4 to crypt destruction, and grade 5 to erosion or ulceration. Higher subgrade scores reflect a more severe condition.
Assessment of fecal calprotectin level in ulcerative colitis patients receiving biological therapy
Time frame: one year
measured by quantative enzyme immuno assay μg/g.
Assessment of the level of PLR, NLR , MLR in ulcerative colitis patients receiving biological therapy
Time frame: one year
by extraction of the values of blood counts in particular WBC and platelet count
Ability of hematological indices and fecal calprotectin to predict histological remission
Time frame: one year
by correlate the level of hematological indices and fecal cal peotectin with histological remission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 32232392Bertani L, Rossari F, Barberio B, Demarzo MG, Tapete G, Albano E, Baiano Svizzero G, Ceccarelli L, Mumolo MG, Brombin C, de Bortoli N, Bellini M, Marchi S, Bodini G, Savarino E, Costa F. Novel Prognostic Biomarkers of Mucosal Healing in Ulcerative Colitis Patients Treated With Anti-TNF: Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio. Inflamm Bowel Dis. 2020 Sep 18;26(10):1579-1587. doi: 10.1093/ibd/izaa062.
- Background: PubMed 27226417Magro F, Lopes SI, Lopes J, Portela F, Cotter J, Lopes S, Moreira MJ, Lago P, Peixe P, Albuquerque A, Rodrigues S, Silva MR, Monteiro P, Lopes C, Monteiro L, Macedo G, Veloso L, Camila C, Afonso J, Geboes K, Carneiro F; Portuguese IBD group [GEDII]. Histological Outcomes and Predictive Value of Faecal Markers in Moderately to Severely Active Ulcerative Colitis Patients Receiving Infliximab. J Crohns Colitis. 2016 Dec;10(12):1407-1416. doi: 10.1093/ecco-jcc/jjw112. Epub 2016 May 25.
- Background: PubMed 32677804Bertani L, Blandizzi C, Mumolo MG, Ceccarelli L, Albano E, Tapete G, Baiano Svizzero G, Zanzi F, Coppini F, de Bortoli N, Bellini M, Morganti R, Marchi S, Costa F. Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study. Clin Transl Gastroenterol. 2020 May;11(5):e00174. doi: 10.14309/ctg.0000000000000174.
- Background: PubMed 32257060Okba AM, Amin MM, Abdelmoaty AS, Ebada HE, Kamel AH, Allam AS, Sobhy OM. Neutrophil/lymphocyte ratio and lymphocyte/monocyte ratio in ulcerative colitis as non-invasive biomarkers of disease activity and severity. Auto Immun Highlights. 2019 May 15;10(1):4. doi: 10.1186/s13317-019-0114-8. eCollection 2019 Dec.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdallah Abdelfadil, specialist (01015549991, abdallah.zidan1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological remission in ulcerative colitis patients receiving biological therapy (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818788, which also lists 4 linked publications.
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 Mar 2021.