Feasibility StudyRota-OmicsNCT07626606
How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia
An observational study of Feasibility Study and Vaccine Immune Response, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial summary
The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Feasibility Study, Vaccine Immune Response, Rota Virus Gastroenteritis
- What is being tested?
- Rotarix®,
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 46 participants
- Where
- 1 siteZambia
- Study dates
- 30 Mar 2026to 30 Sep 2026
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults living in Chawama, a densely populated peri-urban setting in proximity to the study recruitment site.
Who may be able to join
- Age ≥ 18 years and ≤ 50 years.
- Able and willing to provide written informed consent.
- Reside within Lusaka district and available for scheduled follow-up.
- Willing to undergo two endoscopy procedures with serial sample collection.
Who cannot join
- Pregnant or breastfeeding.
- Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).
- Known severe immunodeficiency (HIV with CD4 < 200 cells/mm³, current cancer chemotherapy, systemic corticosteroids equivalent to >20 mg/day prednisolone for >2 weeks).
- Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).
- Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.
- Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration.
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- Any condition judged by the investigator to compromise participant safety or data integrity.
- Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier.
- Pregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy
The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally.
A major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses.
Read more
The RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term "omics" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses.
The study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health.
One important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations.
The study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases.
In addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response.
Overall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.
- Being tested
- Rotarix®,
- Keywords
- Transcriptomics, Feasibility, Microbiome, Immunity, Rotavirus, Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix®,Biological
This is an infant vaccine, but this study participants in this study will receive a double oral Rotarix dose at baseline as per study design.
| Study group | Role | What they receive |
|---|---|---|
| Consenting healthy adult Participants aged ≥ 18 years and ≤ 50 years | Participants will receive a double oral Rotarix dose at baseline. Serial duodenal biopsies will be collected from predefined subgroups to capture early, mid, and late mucosal responses while minimizing per-participant invasive procedures (the sparse sampling design allows construction of profiles of responses over 4 time points while no individual participant undergoes more than 2 endoscopies). The study design avoids confounding from placebo-related procedural differences and allows for robust within-subject longitudinal comparisons. Receives: Biological: Rotarix®, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants completing all scheduled study procedures
The percentage of enrolled participants who complete all scheduled study visits and protocol-defined procedures.
Measured: Through study completion, an average of 1 year.
Sample Quality Control (QC) Success Rate
The proportion of tissue biopsies that successfully meet the defined technical quality control thresholds required for spatial transcriptomic (ST) processing (e.g., RNA integrity number, tissue structural preservation, and spot sequencing depth).
Measured: Through study completion, an average of 1 year.
Proportion of intestinal biopsy samples meeting predefined quality control thresholds
The percentage of collected intestinal biopsy samples meeting predefined quality control criteria for downstream laboratory analysis, including tissue integrity and adequate sample preservation.
Measured: Through study completion, an average of 1 year.
Pre-analytical Sample Processing Efficiency
The precise duration of time (measured in minutes) recorded from the exact moment of clinical biopsy collection to the successful snap-freezing/cryopreservation of the tissue sample.
Measured: Periprocedural
Secondary outcomes (3)
Clinical Follow-up Retention Rate
The percentage of enrolled study participants who successfully complete all scheduled follow-up clinical visits and specimen collection time points as per the study protocol.
Measured: Through study completion, an average of 1 year.
Regulated Gene Expression Profiles
Identification of differentially expressed genes and pathway spatial modules within histologically mapped regions of interest (ROIs) on Hematoxylin and Eosin-stained tissue architectures, analysed via spatially aware linear mixed-effects models.
Measured: Baseline, and up to 52 weeks post-enrollment.
Correlation of Mucosal Spatial Transcriptomics with Systemic Immunity
The statistical relationship (evaluated using Spearman rank correlation coefficients) between tissue-based spatial gene module scores and external serologic or stool-based mucosal immune biomarkers, adjusted for age, sex, and baseline environmental enteric dysfunction (EED) markers.
Measured: Baseline, and up to 52 weeks post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start30 Mar 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Feasibility StudyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Michelo Simuyandi, Master's Degree (MSc), Principal investigator, Centre for Infectious Disease Research in Zambia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626606
- Sponsor's protocol ID
- Rota-Omics 7400-2025
- Acronym
- Rota-Omics
- Status last verified
- Nov 2026
- First submitted
- 18 May 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to requirements of the ethics committee, the study is not permitted to share individual participant data unless otherwise requested for and approved by the University of Zambia Biomedical Research Ethics Committee.
Publications
Kang G. Success from the South: the rotavirus vaccine story and its lessons. Lancet. 2024 Jan 6;403(10421):111-116. doi: 10.1016/S0140-6736(23)02520-5. Epub 2023 Nov 28. No abstract available.
PubMed 38040012Bein A, Fadel CW, Swenor B, Cao W, Powers RK, Camacho DM, Naziripour A, Parsons A, LoGrande N, Sharma S, Kim S, Jalili-Firoozinezhad S, Grant J, Breault DT, Iqbal J, Ali A, Denson LA, Moore SR, Prantil-Baun R, Goyal G, Ingber DE. Nutritional deficiency in an intestine-on-a-chip recapitulates injury hallmarks associated with environmental enteric dysfunction. Nat Biomed Eng. 2022 Nov;6(11):1236-1247. doi: 10.1038/s41551-022-00899-x. Epub 2022 Jun 23.
PubMed 35739419Gu Y, Bartolome-Casado R, Xu C, Bertocchi A, Janney A, Heuberger C, Pearson CF, Teichmann SA, Thornton EE, Powrie F. Immune microniches shape intestinal Treg function. Nature. 2024 Apr;628(8009):854-862. doi: 10.1038/s41586-024-07251-0. Epub 2024 Apr 3.
PubMed 38570678Bhattacharjee A, Burr AHP, Overacre-Delgoffe AE, Tometich JT, Yang D, Huckestein BR, Linehan JL, Spencer SP, Hall JA, Harrison OJ, Morais da Fonseca D, Norton EB, Belkaid Y, Hand TW. Environmental enteric dysfunction induces regulatory T cells that inhibit local CD4+ T cell responses and impair oral vaccine efficacy. Immunity. 2021 Aug 10;54(8):1745-1757.e7. doi: 10.1016/j.immuni.2021.07.005. Epub 2021 Aug 3.
PubMed 34348118Kummerlowe C, Mwakamui S, Hughes TK, Mulugeta N, Mudenda V, Besa E, Zyambo K, Shay JES, Fleming I, Vukovic M, Doran BA, Aicher TP, Wadsworth MH 2nd, Bramante JT, Uchida AM, Fardoos R, Asowata OE, Herbert N, Yilmaz OH, Kloverpris HN, Garber JJ, Ordovas-Montanes J, Gartner ZJ, Wallach T, Shalek AK, Kelly P. Single-cell profiling of environmental enteropathy reveals signatures of epithelial remodeling and immune activation. Sci Transl Med. 2022 Aug 31;14(660):eabi8633. doi: 10.1126/scitranslmed.abi8633. Epub 2022 Aug 31.
PubMed 36044598Marie C, Ali A, Chandwe K, Petri WA Jr, Kelly P. Pathophysiology of environmental enteric dysfunction and its impact on oral vaccine efficacy. Mucosal Immunol. 2018 Sep;11(5):1290-1298. doi: 10.1038/s41385-018-0036-1. Epub 2018 Jul 9.
PubMed 29988114Li H, Wu H, Ma W, Li S, Cai J, Lin Y, Zhang J, Wang Y, Zhang C. Spatial transcriptomics: a bibliometric analysis with large language model on English literatures. Brief Bioinform. 2025 Aug 31;26(5):bbaf553. doi: 10.1093/bib/bbaf553.
PubMed 41139313Tan J, Taitz J, Sun SM, Langford L, Ni D, Macia L. Your Regulatory T Cells Are What You Eat: How Diet and Gut Microbiota Affect Regulatory T Cell Development. Front Nutr. 2022 Apr 20;9:878382. doi: 10.3389/fnut.2022.878382. eCollection 2022.
PubMed 35529463Furusawa Y, Obata Y, Fukuda S, Endo TA, Nakato G, Takahashi D, Nakanishi Y, Uetake C, Kato K, Kato T, Takahashi M, Fukuda NN, Murakami S, Miyauchi E, Hino S, Atarashi K, Onawa S, Fujimura Y, Lockett T, Clarke JM, Topping DL, Tomita M, Hori S, Ohara O, Morita T, Koseki H, Kikuchi J, Honda K, Hase K, Ohno H. Commensal microbe-derived butyrate induces the differentiation of colonic regulatory T cells. Nature. 2013 Dec 19;504(7480):446-50. doi: 10.1038/nature12721. Epub 2013 Nov 13.
PubMed 24226770Atarashi K, Tanoue T, Shima T, Imaoka A, Kuwahara T, Momose Y, Cheng G, Yamasaki S, Saito T, Ohba Y, Taniguchi T, Takeda K, Hori S, Ivanov II, Umesaki Y, Itoh K, Honda K. Induction of colonic regulatory T cells by indigenous Clostridium species. Science. 2011 Jan 21;331(6015):337-41. doi: 10.1126/science.1198469. Epub 2010 Dec 23.
PubMed 21205640Mowat AM, Agace WW. Regional specialization within the intestinal immune system. Nat Rev Immunol. 2014 Oct;14(10):667-85. doi: 10.1038/nri3738. Epub 2014 Sep 19.
PubMed 25234148Church JA, Rukobo S, Govha M, Gough EK, Chasekwa B, Lee B, Carmolli MP, Panic G, Giallourou N, Ntozini R, Mutasa K, McNeal MM, Majo FD, Tavengwa NV, Swann JR, Moulton LH, Kirkpatrick BD, Humphrey JH, Prendergast AJ. Associations between biomarkers of environmental enteric dysfunction and oral rotavirus vaccine immunogenicity in rural Zimbabwean infants. EClinicalMedicine. 2021 Nov 15;41:101173. doi: 10.1016/j.eclinm.2021.101173. eCollection 2021 Nov.
PubMed 34825149Naylor C, Lu M, Haque R, Mondal D, Buonomo E, Nayak U, Mychaleckyj JC, Kirkpatrick B, Colgate R, Carmolli M, Dickson D, van der Klis F, Weldon W, Steven Oberste M; PROVIDE study teams; Ma JZ, Petri WA Jr. Environmental Enteropathy, Oral Vaccine Failure and Growth Faltering in Infants in Bangladesh. EBioMedicine. 2015 Sep 25;2(11):1759-66. doi: 10.1016/j.ebiom.2015.09.036. eCollection 2015 Nov.
PubMed 26870801Hossain MS, Begum SMKN, Rahman MM, Parvez M, Mazumder RN, Sarker SA, Hasan MM, Fahim SM, Gazi MA, Das S, Mahfuz M, Ahmed T. Environmental enteric dysfunction and small intestinal histomorphology of stunted children in Bangladesh. PLoS Negl Trop Dis. 2023 Jan 19;17(1):e0010472. doi: 10.1371/journal.pntd.0010472. eCollection 2023 Jan.
PubMed 36656867Regassa R, Tamiru D, Duguma M, Belachew T. Environmental enteropathy and its association with water sanitation and hygiene in slum areas of Jimma Town Ethiopia. PLoS One. 2023 Jun 23;18(6):e0286866. doi: 10.1371/journal.pone.0286866. eCollection 2023.
PubMed 37352168
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal and Spatial Immune Profiling of Oral Rotavirus Vaccine Responses in Zambian Adults With Environmental Enteropathy
- ClinicalTrials.gov ID
- NCT07626606
- Acronym / sponsor ID
- Rota-Omics / Rota-Omics 7400-2025
- Keywords
- Transcriptomics, Feasibility, Microbiome, Immunity, Rotavirus, Vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 4 Jun 2026 (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.
The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally.
A major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resource settings. EE is associated with damage to the intestinal lining, chronic immune activation, poor nutrient absorption, and impaired gut barrier function. These changes are thought to interfere with the body's ability to respond effectively to oral vaccines, which rely on strong intestinal immune responses.
The RotaOmics study uses a systems biology approach to investigate how the immune system, gut microbiome, nutrition, and intestinal inflammation interact to influence rotavirus vaccine responses. The term "omics" refers to advanced technologies that allow researchers to study genes, proteins, microbes, and other biological processes at a large scale. By combining these approaches, the study aims to identify biological markers and immune pathways associated with strong or weak vaccine responses.
The study involves the collection of samples such as blood, stool, saliva, and breast milk from mothers and infants at different time points before and after vaccination. These samples are analysed using laboratory methods including antibody testing, molecular pathogen detection, microbiome sequencing, and immune profiling. The study also evaluates markers of gut inflammation and intestinal health.
One important goal of the project is to identify correlates of protection, which are measurable biological indicators that predict whether a vaccine is likely to protect against disease. Identifying these markers could help guide the development of improved vaccines or supportive interventions to enhance vaccine performance in vulnerable populations.
The study also contributes to a broader understanding of mucosal immunity, which refers to immune responses occurring in the gastrointestinal tract. Since many enteric infections begin in the gut, understanding intestinal immune function is important not only for rotavirus vaccines but also for other oral vaccines and diarrheal diseases.
In addition to its scientific objectives, RotaOmics includes a strong capacity-building component. The project supports training for local scientists, clinicians, and laboratory personnel in areas such as molecular biology, immunology, genomics, bioinformatics, and data analysis. By strengthening local research expertise and infrastructure, the study aims to support long-term scientific development and improve regional capacity for infectious disease research and outbreak response.
Overall, the RotaOmics study seeks to generate new insights into why oral rotavirus vaccines underperform in some settings and to identify strategies that may improve vaccine effectiveness and child health outcomes in Zambia and similar regions worldwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consenting healthy adult Participants aged ≥ 18 years and ≤ 50 years | – | Biological: Rotarix®,Participants will receive a double oral Rotarix dose at baseline. Serial duodenal biopsies will be collected from predefined subgroups to capture early, mid, and late mucosal responses while minimizing per-participant invasive procedures (the sparse sampling design allows construction of profiles of responses over 4 time points while no individual participant undergoes more than 2 endoscopies). The study design avoids confounding from placebo-related procedural differences and allows for robust within-subject longitudinal comparisons. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults living in Chawama, a densely populated peri-urban setting in proximity to the study recruitment site.
Key inclusion criteria (4 listed)
- Age ≥ 18 years and ≤ 50 years.
- Able and willing to provide written informed consent.
- Reside within Lusaka district and available for scheduled follow-up.
- Willing to undergo two endoscopy procedures with serial sample collection.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding.
- Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding).
- Known severe immunodeficiency (HIV with CD4 < 200 cells/mm³, current cancer chemotherapy, systemic corticosteroids equivalent to >20 mg/day prednisolone for >2 weeks).
- Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities).
- Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated.
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 |
|---|---|---|
| Rotarix®,This is an infant vaccine, but this study participants in this study will receive a double oral Rotarix dose at baseline as per study design. | Biological | Consenting healthy adult Participants aged ≥ 18 years and ≤ 50 years |
Primary outcome
Proportion of participants completing all scheduled study procedures
Time frame: Through study completion, an average of 1 year.
The percentage of enrolled participants who complete all scheduled study visits and protocol-defined procedures.
Sample Quality Control (QC) Success Rate
Time frame: Through study completion, an average of 1 year.
The proportion of tissue biopsies that successfully meet the defined technical quality control thresholds required for spatial transcriptomic (ST) processing (e.g., RNA integrity number, tissue structural preservation, and spot sequencing depth).
Proportion of intestinal biopsy samples meeting predefined quality control thresholds
Time frame: Through study completion, an average of 1 year.
The percentage of collected intestinal biopsy samples meeting predefined quality control criteria for downstream laboratory analysis, including tissue integrity and adequate sample preservation.
Pre-analytical Sample Processing Efficiency
Time frame: Periprocedural
The precise duration of time (measured in minutes) recorded from the exact moment of clinical biopsy collection to the successful snap-freezing/cryopreservation of the tissue sample.
3 secondary outcomes
Clinical Follow-up Retention Rate
Time frame: Through study completion, an average of 1 year.
Regulated Gene Expression Profiles
Time frame: Baseline, and up to 52 weeks post-enrollment.
Correlation of Mucosal Spatial Transcriptomics with Systemic Immunity
Time frame: Baseline, and up to 52 weeks post-enrollment.
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 3 Nov 2026.
- Background: PubMed 38040012Kang G. Success from the South: the rotavirus vaccine story and its lessons. Lancet. 2024 Jan 6;403(10421):111-116. doi: 10.1016/S0140-6736(23)02520-5. Epub 2023 Nov 28. No abstract available.
- Background: PubMed 35739419Bein A, Fadel CW, Swenor B, Cao W, Powers RK, Camacho DM, Naziripour A, Parsons A, LoGrande N, Sharma S, Kim S, Jalili-Firoozinezhad S, Grant J, Breault DT, Iqbal J, Ali A, Denson LA, Moore SR, Prantil-Baun R, Goyal G, Ingber DE. Nutritional deficiency in an intestine-on-a-chip recapitulates injury hallmarks associated with environmental enteric dysfunction. Nat Biomed Eng. 2022 Nov;6(11):1236-1247. doi: 10.1038/s41551-022-00899-x. Epub 2022 Jun 23.
- Background: PubMed 38570678Gu Y, Bartolome-Casado R, Xu C, Bertocchi A, Janney A, Heuberger C, Pearson CF, Teichmann SA, Thornton EE, Powrie F. Immune microniches shape intestinal Treg function. Nature. 2024 Apr;628(8009):854-862. doi: 10.1038/s41586-024-07251-0. Epub 2024 Apr 3.
- Background: PubMed 34348118Bhattacharjee A, Burr AHP, Overacre-Delgoffe AE, Tometich JT, Yang D, Huckestein BR, Linehan JL, Spencer SP, Hall JA, Harrison OJ, Morais da Fonseca D, Norton EB, Belkaid Y, Hand TW. Environmental enteric dysfunction induces regulatory T cells that inhibit local CD4+ T cell responses and impair oral vaccine efficacy. Immunity. 2021 Aug 10;54(8):1745-1757.e7. doi: 10.1016/j.immuni.2021.07.005. Epub 2021 Aug 3.
- Background: PubMed 36044598Kummerlowe C, Mwakamui S, Hughes TK, Mulugeta N, Mudenda V, Besa E, Zyambo K, Shay JES, Fleming I, Vukovic M, Doran BA, Aicher TP, Wadsworth MH 2nd, Bramante JT, Uchida AM, Fardoos R, Asowata OE, Herbert N, Yilmaz OH, Kloverpris HN, Garber JJ, Ordovas-Montanes J, Gartner ZJ, Wallach T, Shalek AK, Kelly P. Single-cell profiling of environmental enteropathy reveals signatures of epithelial remodeling and immune activation. Sci Transl Med. 2022 Aug 31;14(660):eabi8633. doi: 10.1126/scitranslmed.abi8633. Epub 2022 Aug 31.
- Background: PubMed 29988114Marie C, Ali A, Chandwe K, Petri WA Jr, Kelly P. Pathophysiology of environmental enteric dysfunction and its impact on oral vaccine efficacy. Mucosal Immunol. 2018 Sep;11(5):1290-1298. doi: 10.1038/s41385-018-0036-1. Epub 2018 Jul 9.
- Background: PubMed 41139313Li H, Wu H, Ma W, Li S, Cai J, Lin Y, Zhang J, Wang Y, Zhang C. Spatial transcriptomics: a bibliometric analysis with large language model on English literatures. Brief Bioinform. 2025 Aug 31;26(5):bbaf553. doi: 10.1093/bib/bbaf553.
- Background: PubMed 35529463Tan J, Taitz J, Sun SM, Langford L, Ni D, Macia L. Your Regulatory T Cells Are What You Eat: How Diet and Gut Microbiota Affect Regulatory T Cell Development. Front Nutr. 2022 Apr 20;9:878382. doi: 10.3389/fnut.2022.878382. eCollection 2022.
- Background: PubMed 24226770Furusawa Y, Obata Y, Fukuda S, Endo TA, Nakato G, Takahashi D, Nakanishi Y, Uetake C, Kato K, Kato T, Takahashi M, Fukuda NN, Murakami S, Miyauchi E, Hino S, Atarashi K, Onawa S, Fujimura Y, Lockett T, Clarke JM, Topping DL, Tomita M, Hori S, Ohara O, Morita T, Koseki H, Kikuchi J, Honda K, Hase K, Ohno H. Commensal microbe-derived butyrate induces the differentiation of colonic regulatory T cells. Nature. 2013 Dec 19;504(7480):446-50. doi: 10.1038/nature12721. Epub 2013 Nov 13.
- Background: PubMed 21205640Atarashi K, Tanoue T, Shima T, Imaoka A, Kuwahara T, Momose Y, Cheng G, Yamasaki S, Saito T, Ohba Y, Taniguchi T, Takeda K, Hori S, Ivanov II, Umesaki Y, Itoh K, Honda K. Induction of colonic regulatory T cells by indigenous Clostridium species. Science. 2011 Jan 21;331(6015):337-41. doi: 10.1126/science.1198469. Epub 2010 Dec 23.
- Background: PubMed 25234148Mowat AM, Agace WW. Regional specialization within the intestinal immune system. Nat Rev Immunol. 2014 Oct;14(10):667-85. doi: 10.1038/nri3738. Epub 2014 Sep 19.
- Background: PubMed 34825149Church JA, Rukobo S, Govha M, Gough EK, Chasekwa B, Lee B, Carmolli MP, Panic G, Giallourou N, Ntozini R, Mutasa K, McNeal MM, Majo FD, Tavengwa NV, Swann JR, Moulton LH, Kirkpatrick BD, Humphrey JH, Prendergast AJ. Associations between biomarkers of environmental enteric dysfunction and oral rotavirus vaccine immunogenicity in rural Zimbabwean infants. EClinicalMedicine. 2021 Nov 15;41:101173. doi: 10.1016/j.eclinm.2021.101173. eCollection 2021 Nov.
- Individual participant dataSharing planned: No. Due to requirements of the ethics committee, the study is not permitted to share individual participant data unless otherwise requested for and approved by the University of Zambia Biomedical Research Ethics Committee.
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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.
Michelo Simuyandi, Master's Degree (MSc) principal investigator
Centre for Infectious Disease Research in Zambia
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 Feasibility Study and Vaccine Immune Response, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
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 4 inclusion and 9 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 3 Nov 2026. 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 Zambia. 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?
Proportion of participants completing all scheduled study procedures (time frame: Through study completion, an average of 1 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 NCT07626606, which also lists 15 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 3 Nov 2026.