Feeding IntoleranceFMT-FITNCT07640633
FMT for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients
A study testing Fecal microbiota transplantation (FMT) in people with Feeding Intolerance and Gastrointestinal Dysfunction, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Feeding Intolerance, Gastrointestinal Dysfunction, Critically Ill Intensive Care Unit Patients
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years inclusive, regardless of ethnicity or gender;
- Female participants are either non-fertile (i.e., physiologically incapable of pregnancy, including women with ≥2 years of menopause) or have no pregnancy plans;
- Have been admitted to the ICU for ≥24 hours;
- Expected ICU stay ≥7 days after study enrollment;
- Screened positive for ≥1 manifestation of gastrointestinal dysfunction (intra-abdominal hypertension [IAH], massive gastric retention, diarrhea, lower gastrointestinal paralysis, bowel dilatation); enteral nutrition is then implemented under the guidance of the enteral feeding intolerance (FI) score, and participants with persistent FI after a 3-day trial are formally enrolled;
- Participants can actively cooperate or passively complete relevant examinations and follow-up procedures;
- Have signed a written informed consent form.
Who cannot join
- Severe systemic infection in the early resuscitation phase, with hemodynamic instability, insufficient tissue perfusion, or severe fluid-electrolyte and acid-base imbalances;
- Patients assessed by clinicians as having a high risk of death within 5 days, or those with restricted treatment decisions;
- Active gastrointestinal bleeding, perforation, or other conditions with severe intestinal barrier impairment;
- Patients unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stenosis, massive gastrointestinal bleeding, or high-output enterocutaneous fistula;
- Planned or recent abdominal surgery (within 14 days prior to enrollment);
- Current diagnosis of fulminant colitis or toxic megacolon;
Show all 12Show fewer
- Neutropenia (neutrophil count < 1500 cells/µL);
- Patients with congenital or acquired immunodeficiency disorders;
- Recent receipt of high-risk immunosuppressive or cytotoxic agents, e.g., rituximab, doxorubicin, or medium-to-high-dose corticosteroids (≥ 20 mg/day prednisone equivalent) for a duration of > 4 weeks;
- Pregnant or lactating women;
- Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment;
- Doubtful validity of informed consent: subjects with mental illness, intellectual disability, poor motivation, or other factors that restrict the validity of informed consent for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 460022
Jiancheng Zhang, +86-13554105815, zhjcheng1@126.com
About this study
Official title: Fecal Microbiota Transplantation for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients: A Single-Center, Single-Blind, Randomized Controlled Trial
Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay, and increased 90-day mortality.
In critically ill ICU patients, severe gut microbiota dysbiosis and intestinal barrier impairment may occur due to the burden of primary critical illnesses, as well as the administration of proton pump inhibitors and antibiotics. This cascade contributes to a high prevalence of gastrointestinal dysfunction, alongside profound gut-derived systemic inflammatory responses and organ damage. Given the pivotal role of gut microbiota in maintaining intestinal homeostasis, fecal microbiota transplantation (FMT) holds promise as a novel therapeutic strategy for enteral feeding intolerance secondary to gastrointestinal dysfunction in critically ill ICU patients.
This study intends to deliver FMT via a nasojejunal tube to critically ill patients with gastrointestinal dysfunction admitted to the ICU. Its objectives are to evaluate the intervention's effects on gastrointestinal function recovery and the alleviation of enteral feeding intolerance, while also assessing its impacts on intestinal barrier function, gut microbiota composition and metabolic profiles, serum metabolite signatures, immune-inflammatory responses (including lymphocyte subsets, cytokines, C-reactive protein, and procalcitonin), ICU delirium, ICU sleep quality, and clinical outcomes (encompassing ICU mortality, in-hospital mortality, 28-day all-cause mortality, 90-day all-cause mortality, 90-day readmission rate, and 90-day incidence of secondary infections).
- Conditions
- Feeding Intolerance, Gastrointestinal Dysfunction, Critically Ill Intensive Care Unit Patients
- Being tested
- Fecal microbiota transplantation (FMT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Other
Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients received standard ICU care. |
| FMT intervention group | Experimental | Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days. Receives: Other: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral nutrition FI improvement rate
Measured: 24, 48, 72, 96, and 120 hours after study enrollment
Secondary outcomes (17)
Gut microbiota composition as well as α and β diversity measured from rectal swabs by 16S rRNA gene sequencing
Measured: 24-0 hours and 120 hours after study enrollment
Fecal metabolite profile (by untargeted LC-MS) from rectal swabs
Measured: 24-0 hours and 120 hours after study enrollment
Serum metabolite profile (by untargeted LC-MS)
Measured: 24-0 hours and 120 hours after study enrollment
Serum level of citrulline
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
APACHE II score
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
SOFA score
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Cumulative intravenous dose of vasopressor agents (including norepinephrine, epinephrine, dobutamine, etc.)
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of C-reactive protein
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of procalcitonin
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Peripheral blood level of cytokines (including IL-6, IL-17, TNF-α, IL-10, IL-1β, etc.)
Measured: 0 and 120 hours after study enrollment
Peripheral blood lymphocyte subsets (including CD4+ T, CD8+ T, B lymphocytes, NK cells, etc.)
Measured: 0, 24, 48, 72, 96, and 120 hours after study enrollment
ICU mortality
Measured: Within 28 days after study enrollment
In-hospital mortality
Measured: Within 60 days after study enrollment
28-day all-cause mortality
Measured: Within 28 days after study enrollment
90-day all-cause mortality
Measured: Within 90 days after study enrollment
90-day readmission rate
Measured: Within 90 days after study enrollment
90-day secondary infection rate
Measured: Within 90 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Feeding IntoleranceStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiancheng Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640633
- Sponsor's protocol ID
- zjc202402
- Acronym
- FMT-FIT
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Uhde M, Ajamian M, Caio G, De Giorgio R, Indart A, Green PH, Verna EC, Volta U, Alaedini A. Intestinal cell damage and systemic immune activation in individuals reporting sensitivity to wheat in the absence of coeliac disease. Gut. 2016 Dec;65(12):1930-1937. doi: 10.1136/gutjnl-2016-311964. Epub 2016 Jul 25.
PubMed 27459152Heming N, Carlier R, Prigent H, Mekki A, Jousset C, Lofaso F, Ambrosi X, Bounab R, Maxime V, Mansart A, Crenn P, Moine P, Foltzer F, Cuenoud B, Konz T, Corthesy J, Beaumont M, Hartweg M, Roessle C, Preiser JC, Breuille D, Annane D. Effect of an enteral amino acid blend on muscle and gut functionality in critically ill patients: a proof-of-concept randomized controlled trial. Crit Care. 2022 Nov 17;26(1):358. doi: 10.1186/s13054-022-04232-5.
PubMed 36397118Piton G, Manzon C, Cypriani B, Carbonnel F, Capellier G. Acute intestinal failure in critically ill patients: is plasma citrulline the right marker? Intensive Care Med. 2011 Jun;37(6):911-7. doi: 10.1007/s00134-011-2172-x. Epub 2011 Mar 12.
PubMed 21400011Yadegar A, Bar-Yoseph H, Monaghan TM, Pakpour S, Severino A, Kuijper EJ, Smits WK, Terveer EM, Neupane S, Nabavi-Rad A, Sadeghi J, Cammarota G, Ianiro G, Nap-Hill E, Leung D, Wong K, Kao D. Fecal microbiota transplantation: current challenges and future landscapes. Clin Microbiol Rev. 2024 Jun 13;37(2):e0006022. doi: 10.1128/cmr.00060-22. Epub 2024 May 8.
PubMed 38717124McClave SA, Patel J, Bhutiani N. Should fecal microbial transplantation be used in the ICU? Curr Opin Crit Care. 2018 Apr;24(2):105-111. doi: 10.1097/MCC.0000000000000489.
PubMed 29432297Beyi AF, Wannemuehler M, Plummer PJ. Impacts of Gut Microbiota on the Immune System and Fecal Microbiota Transplantation as a Re-Emerging Therapy for Autoimmune Diseases. Antibiotics (Basel). 2022 Aug 12;11(8):1093. doi: 10.3390/antibiotics11081093.
PubMed 36009962Schluter J, Peled JU, Taylor BP, Markey KA, Smith M, Taur Y, Niehus R, Staffas A, Dai A, Fontana E, Amoretti LA, Wright RJ, Morjaria S, Fenelus M, Pessin MS, Chao NJ, Lew M, Bohannon L, Bush A, Sung AD, Hohl TM, Perales MA, van den Brink MRM, Xavier JB. The gut microbiota is associated with immune cell dynamics in humans. Nature. 2020 Dec;588(7837):303-307. doi: 10.1038/s41586-020-2971-8. Epub 2020 Nov 25.
PubMed 33239790Arunachala Murthy T, Chapple LS, Lange K, Marathe CS, Horowitz M, Peake SL, Chapman MJ. Gastrointestinal dysfunction during enteral nutrition delivery in intensive care unit (ICU) patients: Risk factors, natural history, and clinical implications. A post-hoc analysis of The Augmented versus Routine approach to Giving Energy Trial (TARGET). Am J Clin Nutr. 2022 Aug 4;116(2):589-598. doi: 10.1093/ajcn/nqac113.
PubMed 35472097Deane A, Chapman MJ, Fraser RJ, Bryant LK, Burgstad C, Nguyen NQ. Mechanisms underlying feed intolerance in the critically ill: implications for treatment. World J Gastroenterol. 2007 Aug 7;13(29):3909-17. doi: 10.3748/wjg.v13.i29.3909.
PubMed 17663503Nguyen NQ, Fraser RJ, Chapman MJ, Bryant LK, Holloway RH, Vozzo R, Wishart J, Feinle-Bisset C, Horowitz M. Feed intolerance in critical illness is associated with increased basal and nutrient-stimulated plasma cholecystokinin concentrations. Crit Care Med. 2007 Jan;35(1):82-8. doi: 10.1097/01.CCM.0000250317.10791.6C.
PubMed 17095943
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Feeding Intolerance Due to Gastrointestinal Dysfunction in Critically Ill Patients: A Single-Center, Single-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07640633
- Acronym / sponsor ID
- FMT-FIT / zjc202402
- Conditions
- Feeding Intolerance, Gastrointestinal Dysfunction, Critically Ill Intensive Care Unit Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 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.
Critically ill patients admitted to the intensive care unit (ICU) frequently present with gastrointestinal dysfunction and are at elevated risk of malnutrition. Gastrointestinal dysfunction is correlated with adverse clinical outcomes, including prolonged mechanical ventilation duration, extended ICU length of stay, and increased 90-day mortality.
In critically ill ICU patients, severe gut microbiota dysbiosis and intestinal barrier impairment may occur due to the burden of primary critical illnesses, as well as the administration of proton pump inhibitors and antibiotics. This cascade contributes to a high prevalence of gastrointestinal dysfunction, alongside profound gut-derived systemic inflammatory responses and organ damage. Given the pivotal role of gut microbiota in maintaining intestinal homeostasis, fecal microbiota transplantation (FMT) holds promise as a novel therapeutic strategy for enteral feeding intolerance secondary to gastrointestinal dysfunction in critically ill ICU patients.
This study intends to deliver FMT via a nasojejunal tube to critically ill patients with gastrointestinal dysfunction admitted to the ICU. Its objectives are to evaluate the intervention's effects on gastrointestinal function recovery and the alleviation of enteral feeding intolerance, while also assessing its impacts on intestinal barrier function, gut microbiota composition and metabolic profiles, serum metabolite signatures, immune-inflammatory responses (including lymphocyte subsets, cytokines, C-reactive protein, and procalcitonin), ICU delirium, ICU sleep quality, and clinical outcomes (encompassing ICU mortality, in-hospital mortality, 28-day all-cause mortality, 90-day all-cause mortality, 90-day readmission rate, and 90-day incidence of secondary infections).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients received standard ICU care. |
| FMT intervention group | Experimental | Other: Fecal microbiota transplantation (FMT)Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 70 years inclusive, regardless of ethnicity or gender;
- Female participants are either non-fertile (i.e., physiologically incapable of pregnancy, including women with ≥2 years of menopause) or have no pregnancy plans;
- Have been admitted to the ICU for ≥24 hours;
- Expected ICU stay ≥7 days after study enrollment;
- Screened positive for ≥1 manifestation of gastrointestinal dysfunction (intra-abdominal hypertension [IAH], massive gastric retention, diarrhea, lower gastrointestinal paralysis, bowel dilatation); enteral nutrition is then implemented under the guidance of the enteral feeding intolerance (FI) score, and participants with persistent FI after a 3-day trial are formally enrolled;
Key exclusion criteria (12 listed)
- Severe systemic infection in the early resuscitation phase, with hemodynamic instability, insufficient tissue perfusion, or severe fluid-electrolyte and acid-base imbalances;
- Patients assessed by clinicians as having a high risk of death within 5 days, or those with restricted treatment decisions;
- Active gastrointestinal bleeding, perforation, or other conditions with severe intestinal barrier impairment;
- Patients unable to tolerate enteral nutrition meeting 50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stenosis, massive gastrointestinal bleeding, or high-output enterocutaneous fistula;
- Planned or recent abdominal surgery (within 14 days prior to enrollment);
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 |
|---|---|---|
| Fecal microbiota transplantation (FMT)Patients received FMT via a nasojejunal tube in addition to standard ICU care. Specifically, 50-100 mL of intestinal microbiota suspension was administered daily via the nasojejunal tube between 11:00 and 13:00 for three consecutive days. | Other | FMT intervention group |
Primary outcome
Enteral nutrition FI improvement rate
Time frame: 24, 48, 72, 96, and 120 hours after study enrollment
17 secondary outcomes
Gut microbiota composition as well as α and β diversity measured from rectal swabs by 16S rRNA gene sequencing
Time frame: 24-0 hours and 120 hours after study enrollment
Fecal metabolite profile (by untargeted LC-MS) from rectal swabs
Time frame: 24-0 hours and 120 hours after study enrollment
Serum metabolite profile (by untargeted LC-MS)
Time frame: 24-0 hours and 120 hours after study enrollment
Serum level of citrulline
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
APACHE II score
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
SOFA score
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Cumulative intravenous dose of vasopressor agents (including norepinephrine, epinephrine, dobutamine, etc.)
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of C-reactive protein
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Serum level of procalcitonin
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
Peripheral blood level of cytokines (including IL-6, IL-17, TNF-α, IL-10, IL-1β, etc.)
Time frame: 0 and 120 hours after study enrollment
Peripheral blood lymphocyte subsets (including CD4+ T, CD8+ T, B lymphocytes, NK cells, etc.)
Time frame: 0, 24, 48, 72, 96, and 120 hours after study enrollment
ICU mortality
Time frame: Within 28 days after study enrollment
In-hospital mortality
Time frame: Within 60 days after study enrollment
28-day all-cause mortality
Time frame: Within 28 days after study enrollment
90-day all-cause mortality
Time frame: Within 90 days after study enrollment
90-day readmission rate
Time frame: Within 90 days after study enrollment
90-day secondary infection rate
Time frame: Within 90 days after study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 27459152Uhde M, Ajamian M, Caio G, De Giorgio R, Indart A, Green PH, Verna EC, Volta U, Alaedini A. Intestinal cell damage and systemic immune activation in individuals reporting sensitivity to wheat in the absence of coeliac disease. Gut. 2016 Dec;65(12):1930-1937. doi: 10.1136/gutjnl-2016-311964. Epub 2016 Jul 25.
- Background: PubMed 36397118Heming N, Carlier R, Prigent H, Mekki A, Jousset C, Lofaso F, Ambrosi X, Bounab R, Maxime V, Mansart A, Crenn P, Moine P, Foltzer F, Cuenoud B, Konz T, Corthesy J, Beaumont M, Hartweg M, Roessle C, Preiser JC, Breuille D, Annane D. Effect of an enteral amino acid blend on muscle and gut functionality in critically ill patients: a proof-of-concept randomized controlled trial. Crit Care. 2022 Nov 17;26(1):358. doi: 10.1186/s13054-022-04232-5.
- Background: PubMed 21400011Piton G, Manzon C, Cypriani B, Carbonnel F, Capellier G. Acute intestinal failure in critically ill patients: is plasma citrulline the right marker? Intensive Care Med. 2011 Jun;37(6):911-7. doi: 10.1007/s00134-011-2172-x. Epub 2011 Mar 12.
- Background: PubMed 38717124Yadegar A, Bar-Yoseph H, Monaghan TM, Pakpour S, Severino A, Kuijper EJ, Smits WK, Terveer EM, Neupane S, Nabavi-Rad A, Sadeghi J, Cammarota G, Ianiro G, Nap-Hill E, Leung D, Wong K, Kao D. Fecal microbiota transplantation: current challenges and future landscapes. Clin Microbiol Rev. 2024 Jun 13;37(2):e0006022. doi: 10.1128/cmr.00060-22. Epub 2024 May 8.
- Background: PubMed 29432297McClave SA, Patel J, Bhutiani N. Should fecal microbial transplantation be used in the ICU? Curr Opin Crit Care. 2018 Apr;24(2):105-111. doi: 10.1097/MCC.0000000000000489.
- Background: PubMed 36009962Beyi AF, Wannemuehler M, Plummer PJ. Impacts of Gut Microbiota on the Immune System and Fecal Microbiota Transplantation as a Re-Emerging Therapy for Autoimmune Diseases. Antibiotics (Basel). 2022 Aug 12;11(8):1093. doi: 10.3390/antibiotics11081093.
- Background: PubMed 33239790Schluter J, Peled JU, Taylor BP, Markey KA, Smith M, Taur Y, Niehus R, Staffas A, Dai A, Fontana E, Amoretti LA, Wright RJ, Morjaria S, Fenelus M, Pessin MS, Chao NJ, Lew M, Bohannon L, Bush A, Sung AD, Hohl TM, Perales MA, van den Brink MRM, Xavier JB. The gut microbiota is associated with immune cell dynamics in humans. Nature. 2020 Dec;588(7837):303-307. doi: 10.1038/s41586-020-2971-8. Epub 2020 Nov 25.
- Background: PubMed 35472097Arunachala Murthy T, Chapple LS, Lange K, Marathe CS, Horowitz M, Peake SL, Chapman MJ. Gastrointestinal dysfunction during enteral nutrition delivery in intensive care unit (ICU) patients: Risk factors, natural history, and clinical implications. A post-hoc analysis of The Augmented versus Routine approach to Giving Energy Trial (TARGET). Am J Clin Nutr. 2022 Aug 4;116(2):589-598. doi: 10.1093/ajcn/nqac113.
- Background: PubMed 17663503Deane A, Chapman MJ, Fraser RJ, Bryant LK, Burgstad C, Nguyen NQ. Mechanisms underlying feed intolerance in the critically ill: implications for treatment. World J Gastroenterol. 2007 Aug 7;13(29):3909-17. doi: 10.3748/wjg.v13.i29.3909.
- Background: PubMed 17095943Nguyen NQ, Fraser RJ, Chapman MJ, Bryant LK, Holloway RH, Vozzo R, Wishart J, Feinle-Bisset C, Horowitz M. Feed intolerance in critical illness is associated with increased basal and nutrient-stimulated plasma cholecystokinin concentrations. Crit Care Med. 2007 Jan;35(1):82-8. doi: 10.1097/01.CCM.0000250317.10791.6C.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation (FMT) in people with Feeding Intolerance and Gastrointestinal Dysfunction, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Sep 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiancheng Zhang (+86-13554105815, zhjcheng1@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteral nutrition FI improvement rate (time frame: 24, 48, 72, 96, and 120 hours after study enrollment). 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 NCT07640633, which also lists 10 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 16 Sep 2026.