Inflammatory Bowel DiseasesEarly Phase 1NCT04223518
Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)
A Early Phase 1 study testing Serum bovine immunoglobulin in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Monisha Hitesh Shah at 1 site in United States.
Trial summary
This is a randomized, double-blind placebo controlled study to assess for safety, tolerability and nutritional impact of oral serum bovine immunoglobulin (SBI) on pediatric patients and young adults with inflammatory bowel disease (IBD) as assessed by an increase in serum albumin and other nutritional markers… Read more about this study
- Who is it for?
- Ages 6 to 30 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- Serum bovine immunoglobulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2020to 31 May 2025
- Phase
- Early Phase 1
- 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 6 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients, ages 6-30 years diagnosed with inflammatory bowel disease (UC/Crohn's disease) based on the pediatric ulcerative colitis activity index/ short pediatric Crohn's disease activity index for children and Harvey Bradshaw Index/SCCAI for young adults
Who cannot join
- Patients with severe illness requiring inpatient admission
- Patients with known allergy to beef or beef products, sunflower lecithin and dextrose
- Patients with liver function tests elevated to more than 3 times the upper limit of normal
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease
This is a randomized, double-blind placebo controlled study to assess for safety, tolerability and nutritional impact of oral serum bovine immunoglobulin (SBI) on pediatric patients and young adults with inflammatory bowel disease (IBD) as assessed by an increase in serum albumin and other nutritional markers including vitamin D level, pre-albumin, transferrin and iron saturation; and improvement in weight and body mass index. SBI is an animal derived protein isolate from the serum of cows containing >50% IgG. It has been used for patients suffering from irritable bowel syndrome, human immunodeficiency virus enteropathy and antibiotic-associated diarrhea for symptomatic relief of diarrhea with good results and minimal side effects. However its role in IBD has not yet been investigated. The investigators hypothesize that the study product will have a positive nutritional impact along with symptom improvement for pediatric and young adult patients with IBD. The volunteers for our study will have established Crohn's disease or ulcerative colitis and will be treated with a daily powder (SBI or placebo) added to their breakfast food (egg, yogurt, or peanut butter are best) for total of 60 days followed by 30 day monitoring period after completion of treatment. The volunteers will be followed by clinic visits and labs on day 0, day 15, day 60 and day 90. There is the potential for the treatment to alter disease activity, a secondary outcome, as assessed by measurement of serum markers of inflammation (ESR, CRP), fecal calprotectin (validated marker of intestinal inflammation), and clinical indices like short pediatric Crohn's disease activity index (shPDCAI) or pediatric ulcerative colitis activity index (PUCAI) for children and Harvey Bradshaw Index or SCCAI for adults. Stool samples will be collected on day 0 and day 60 for 16S RNA sequencing to assess for changes in microbiota of the participants while on the study product/placebo. We plan to enroll 43 patients in the study to allow for data analysis of atleast 30 patients. The study will take place over 1 year and will be conducted at University of Texas-Children's Memorial Hermann Hospital, where we follow > 125 children with inflammatory bowel disease.
- Being tested
- Serum bovine immunoglobulin, Placebo
- Keywords
- serum bovine immunoglobulin
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum bovine immunoglobulinDietary supplement
Also called Enteragam
Serum bovine immunoglobulin (SBI), also known by the brand name of Enteragam (Proliant Biologicals, Ankeny, Iowa) is derived from bovine serum and classified as a medical food composed of >90% protein which consists primarily of immunoglobulins (>50% of IgG) along with other bovine proteins and peptides similar to those commonly consumed by humans in beef products.
PlaceboDietary supplement
Hydrolyzed Collagen
| Study group | Role | What they receive |
|---|---|---|
| Serum Bovine Immunoglobulin | Active comparator | Study product: Serum bovine immunoglobulin, also known by the trade name of Enteragam Dosage form: powdered packet Dosage: Each packet (10 g net weight) consists of 5 g of serum-derived bovine immunoglobulin/protein isolate (SBI) which is the active ingredient Frequency: one packet a day Duration: 60 days Receives: Dietary Supplement: Serum bovine immunoglobulin |
| Hydrolyzed Collagen | Placebo comparator | Placebo: hydrolyzed collagen Dosage form: powdered packet Dosage: 10 g of hydrolyzed collagen per packet Frequency: one packet a day Duration: 60 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease
Assessed by a change in albumin by at least 5% (primary end point)
Measured: Days 0, 15, 60 and 90
Secondary outcomes (13)
Effects of SBI on nutritional marker: Vitamin D
Assessed quantitative valuation of 25-hydroxy vitamin D level in ng/mL
Measured: Days 0 and 60
Effects of SBI on nutritional marker: pre-albumin
Assessed quantitative valuation of pre-albumin level in mg/dL
Measured: Days 0 and 60
Effects of SBI on nutritional markers: transferrin and iron saturation
Assessed quantitative valuation of iron panel
Measured: Days 0 and 60
Effects of SBI on weight
Assessed quantitative valuation of weight in kilograms
Measured: Days 0, 15, 60 and 90
Effects of SBI on Body Mass Index (BMI)
Assessed quantitative valuation of Body Mass Index (BMI) in kg/m2
Measured: Days 0, 15, 60 and 90
Safety assessment for kidney function
Assessed quantitative valuation of kidney function as assessed by measurement of creatinine and Blood urea nitrogen (BUN) levels in mg/dL
Measured: Days 0, 15, 60 and 90
Safety assessment for liver function
Assessed quantitative valuation of liver function as assessed by measurement of alanine transaminase (ALT) and aspartate aminotransferase (AST) in IU/L
Measured: Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for ulcerative colitis
Assessed quantitative valuation of clinical activity index: Pediatric Ulcerative Colitis Activity Index (PUCAI) score for children with ulcerative colitis and Simple Clinical Colitis Activity Index (SCCAI) for young adults with ulcerative colitis . Minimum and maximum values are 0 and 85 respectively for PUCAI and 0 and 19 for SCCAI, with higher scores relating to worse outcome.
Measured: Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for Crohn's disease
Assessed quantitative valuation of clinical activity index: Short Pediatric Crohn's Disease Activity Index (shPCDAI) for children with Crohn's disease and Harvey Bradshaw Index(HBI) for young adults with Crohn's disease. Minimum and maximum values are 0 and 90 respectively for shPDCAI and 0 and >16 for HBI, with higher scores relating to worse outcome.
Measured: Days 0, 15, 60 and 90
Effect of SBI on disease activity (ESR)
Assessed quantitative valuation of serum inflammatory marker: ESR measured in mm/hr
Measured: Days 0 and 60
Effect of SBI on disease activity (CRP)
Assessed quantitative valuation of serum inflammatory marker: CRP measured in mg/L
Measured: Days 0, 15, 60 and 90
Effect of SBI on disease activity (calprotectin)
Assessed quantitative valuation of fecal inflammatory marker: calprotectin measured in ug/g
Measured: Days 0 and 60
Effect of SBI on stool microbiota
Assessed quantitative valuation of stool microbial community profiling by denaturing high pressure liquid chromatography (DHPLC) using broad range 16S rDNA PCR sequencing and bioinformatics
Measured: Days 0 and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start20 Sep 2020
- Primary completion31 May 2025
- Study completion31 May 2025
Why it stopped: Lack of study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized control double blinded prospective clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monisha Hitesh Shah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monisha Hitesh Shah, The University of Texas Health Science Center, Houston
- Investigators
- Monisha Shah, M.D., Principal investigator, The University of Texas Health Science Center, HoustonJon Marc Rhoads, M.D., Study director, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04223518
- Sponsor's protocol ID
- HSC-MS-19-0998
- Status last verified
- Jun 2025
- First submitted
- 6 Jan 2020
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arrouk R, Herdes RE, Karpinski AC, Hyman PE. Serum-derived bovine immunoglobulin for children with diarrhea-predominant irritable bowel syndrome. Pediatric Health Med Ther. 2018 Oct 24;9:129-133. doi: 10.2147/PHMT.S159925. eCollection 2018.
PubMed 30498390Liaquat H, Ashat M, Stocker A, McElmurray L, Beatty K, Abell TL, Dryden G. Clinical Efficacy of Serum-Derived Bovine Immunoglobulin in Patients With Refractory Inflammatory Bowel Disease. Am J Med Sci. 2018 Dec;356(6):531-536. doi: 10.1016/j.amjms.2018.08.019. Epub 2018 Sep 5.
PubMed 30342719Soriano RA, Ramos-Soriano AG. Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen. Case Rep Gastroenterol. 2017 May 19;11(2):335-343. doi: 10.1159/000475923. eCollection 2017 May-Aug.
PubMed 28626380Shaw AL, Tomanelli A, Bradshaw TP, Petschow BW, Burnett BP. Impact of serum-derived bovine immunoglobulin/protein isolate therapy on irritable bowel syndrome and inflammatory bowel disease: a survey of patient perspective. Patient Prefer Adherence. 2017 May 31;11:1001-1007. doi: 10.2147/PPA.S134792. eCollection 2017.
PubMed 28615929Valentin N, Camilleri M, Carlson P, Harrington SC, Eckert D, O'Neill J, Burton D, Chen J, Shaw AL, Acosta A. Potential mechanisms of effects of serum-derived bovine immunoglobulin/protein isolate therapy in patients with diarrhea-predominant irritable bowel syndrome. Physiol Rep. 2017 Mar;5(5):e13170. doi: 10.14814/phy2.13170.
PubMed 28275113Perez-Bosque A, Miro L, Maijo M, Polo J, Campbell JM, Russell L, Crenshaw JD, Weaver E, Moreto M. Oral Serum-Derived Bovine Immunoglobulin/Protein Isolate Has Immunomodulatory Effects on the Colon of Mice that Spontaneously Develop Colitis. PLoS One. 2016 May 3;11(5):e0154823. doi: 10.1371/journal.pone.0154823. eCollection 2016.
PubMed 27139220Gelfand MS, Burnett BP. Serum-derived bovine immunoglobulin/protein isolate should be considered in patients with HIV gut barrier dysfunction. Infection. 2015 Apr;43(2):253-4. doi: 10.1007/s15010-015-0732-7. Epub 2015 Jan 30. No abstract available.
PubMed 25633465
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04223518
- Acronym / sponsor ID
- HSC-MS-19-0998
- Keywords
- serum bovine immunoglobulin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of study participants
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Monisha Hitesh ShahUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 10 Jan 2020 (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.
This is a randomized, double-blind placebo controlled study to assess for safety, tolerability and nutritional impact of oral serum bovine immunoglobulin (SBI) on pediatric patients and young adults with inflammatory bowel disease (IBD) as assessed by an increase in serum albumin and other nutritional markers including vitamin D level, pre-albumin, transferrin and iron saturation; and improvement in weight and body mass index. SBI is an animal derived protein isolate from the serum of cows containing >50% IgG. It has been used for patients suffering from irritable bowel syndrome, human immunodeficiency virus enteropathy and antibiotic-associated diarrhea for symptomatic relief of diarrhea with good results and minimal side effects. However its role in IBD has not yet been investigated. The investigators hypothesize that the study product will have a positive nutritional impact along with symptom improvement for pediatric and young adult patients with IBD. The volunteers for our study will have established Crohn's disease or ulcerative colitis and will be treated with a daily powder (SBI or placebo) added to their breakfast food (egg, yogurt, or peanut butter are best) for total of 60 days followed by 30 day monitoring period after completion of treatment. The volunteers will be followed by clinic visits and labs on day 0, day 15, day 60 and day 90. There is the potential for the treatment to alter disease activity, a secondary outcome, as assessed by measurement of serum markers of inflammation (ESR, CRP), fecal calprotectin (validated marker of intestinal inflammation), and clinical indices like short pediatric Crohn's disease activity index (shPDCAI) or pediatric ulcerative colitis activity index (PUCAI) for children and Harvey Bradshaw Index or SCCAI for adults. Stool samples will be collected on day 0 and day 60 for 16S RNA sequencing to assess for changes in microbiota of the participants while on the study product/placebo. We plan to enroll 43 patients in the study to allow for data analysis of atleast 30 patients. The study will take place over 1 year and will be conducted at University of Texas-Children's Memorial Hermann Hospital, where we follow > 125 children with inflammatory bowel disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Single-center, randomized control double blinded prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| Serum Bovine Immunoglobulin | Active comparator | Dietary Supplement: Serum bovine immunoglobulinStudy product: Serum bovine immunoglobulin, also known by the trade name of Enteragam Dosage form: powdered packet Dosage: Each packet (10 g net weight) consists of 5 g of serum-derived bovine immunoglobulin/protein isolate (SBI) which is the active ingredient Frequency: one packet a day Duration: 60 days |
| Hydrolyzed Collagen | Placebo comparator | Dietary Supplement: PlaceboPlacebo: hydrolyzed collagen Dosage form: powdered packet Dosage: 10 g of hydrolyzed collagen per packet Frequency: one packet a day Duration: 60 days |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients, ages 6-30 years diagnosed with inflammatory bowel disease (UC/Crohn's disease) based on the pediatric ulcerative colitis activity index/ short pediatric Crohn's disease activity index for children and Harvey Bradshaw Index/SCCAI for young adults
Key exclusion criteria (4 listed)
- Patients with severe illness requiring inpatient admission
- Patients with known allergy to beef or beef products, sunflower lecithin and dextrose
- Patients with liver function tests elevated to more than 3 times the upper limit of normal
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Serum bovine immunoglobulinAlso: EnteragamSerum bovine immunoglobulin (SBI), also known by the brand name of Enteragam (Proliant Biologicals, Ankeny, Iowa) is derived from bovine serum and classified as a medical food composed of >90% protein which consists primarily of immunoglobulins (>50% of IgG) along with other bovine proteins and peptides similar to those commonly consumed by humans in beef products. | Dietary supplement | Serum Bovine Immunoglobulin |
| PlaceboHydrolyzed Collagen | Dietary supplement | Hydrolyzed Collagen |
Primary outcome
Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease
Time frame: Days 0, 15, 60 and 90
Assessed by a change in albumin by at least 5% (primary end point)
13 secondary outcomes
Effects of SBI on nutritional marker: Vitamin D
Time frame: Days 0 and 60
Effects of SBI on nutritional marker: pre-albumin
Time frame: Days 0 and 60
Effects of SBI on nutritional markers: transferrin and iron saturation
Time frame: Days 0 and 60
Effects of SBI on weight
Time frame: Days 0, 15, 60 and 90
Effects of SBI on Body Mass Index (BMI)
Time frame: Days 0, 15, 60 and 90
Safety assessment for kidney function
Time frame: Days 0, 15, 60 and 90
Safety assessment for liver function
Time frame: Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for ulcerative colitis
Time frame: Days 0, 15, 60 and 90
Effect of SBI on symptom of diarrhea for Crohn's disease
Time frame: Days 0, 15, 60 and 90
Effect of SBI on disease activity (ESR)
Time frame: Days 0 and 60
Effect of SBI on disease activity (CRP)
Time frame: Days 0, 15, 60 and 90
Effect of SBI on disease activity (calprotectin)
Time frame: Days 0 and 60
Effect of SBI on stool microbiota
Time frame: Days 0 and 60
Results and safety
The study was stopped early (reason given: Lack of study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Results publication: PubMed 30498390Arrouk R, Herdes RE, Karpinski AC, Hyman PE. Serum-derived bovine immunoglobulin for children with diarrhea-predominant irritable bowel syndrome. Pediatric Health Med Ther. 2018 Oct 24;9:129-133. doi: 10.2147/PHMT.S159925. eCollection 2018.
- Results publication: PubMed 30342719Liaquat H, Ashat M, Stocker A, McElmurray L, Beatty K, Abell TL, Dryden G. Clinical Efficacy of Serum-Derived Bovine Immunoglobulin in Patients With Refractory Inflammatory Bowel Disease. Am J Med Sci. 2018 Dec;356(6):531-536. doi: 10.1016/j.amjms.2018.08.019. Epub 2018 Sep 5.
- Results publication: PubMed 28626380Soriano RA, Ramos-Soriano AG. Clinical and Pathologic Remission of Pediatric Ulcerative Colitis with Serum-Derived Bovine Immunoglobulin Added to the Standard Treatment Regimen. Case Rep Gastroenterol. 2017 May 19;11(2):335-343. doi: 10.1159/000475923. eCollection 2017 May-Aug.
- Results publication: PubMed 28615929Shaw AL, Tomanelli A, Bradshaw TP, Petschow BW, Burnett BP. Impact of serum-derived bovine immunoglobulin/protein isolate therapy on irritable bowel syndrome and inflammatory bowel disease: a survey of patient perspective. Patient Prefer Adherence. 2017 May 31;11:1001-1007. doi: 10.2147/PPA.S134792. eCollection 2017.
- Results publication: PubMed 28275113Valentin N, Camilleri M, Carlson P, Harrington SC, Eckert D, O'Neill J, Burton D, Chen J, Shaw AL, Acosta A. Potential mechanisms of effects of serum-derived bovine immunoglobulin/protein isolate therapy in patients with diarrhea-predominant irritable bowel syndrome. Physiol Rep. 2017 Mar;5(5):e13170. doi: 10.14814/phy2.13170.
- Results publication: PubMed 27139220Perez-Bosque A, Miro L, Maijo M, Polo J, Campbell JM, Russell L, Crenshaw JD, Weaver E, Moreto M. Oral Serum-Derived Bovine Immunoglobulin/Protein Isolate Has Immunomodulatory Effects on the Colon of Mice that Spontaneously Develop Colitis. PLoS One. 2016 May 3;11(5):e0154823. doi: 10.1371/journal.pone.0154823. eCollection 2016.
- Results publication: PubMed 25633465Gelfand MS, Burnett BP. Serum-derived bovine immunoglobulin/protein isolate should be considered in patients with HIV gut barrier dysfunction. Infection. 2015 Apr;43(2):253-4. doi: 10.1007/s15010-015-0732-7. Epub 2015 Jan 30. No abstract available.
- Official study product website containing detailed information about study product, uses and side effects.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Monisha Shah, M.D. principal investigator
The University of Texas Health Science Center, Houston
Jon Marc Rhoads, M.D. study director
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Serum bovine immunoglobulin in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Monisha Hitesh Shah at 1 site in United States.
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: stopped early, as of the sponsor's last update on 12 Jun 2025. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of study participants). Results are not available in the source record.
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?
Effects of Serum Bovine Immunoglobulin (SBI) on nutrition of pediatric patients with inflammatory Bowel Disease (time frame: Days 0, 15, 60 and 90). 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 NCT04223518, which also lists 7 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 12 Jun 2025.