Ileostomy StomaSTIMICNCT07640113
Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings
A study testing Serum stimulation and Physiological stimulation in people with Ileostomy Stoma and Stoma Stimulation, run by Hospital Clinic of Barcelona.
Trial summary
BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy Stoma, Stoma Stimulation, Microbiome Analysis
- What is being tested?
- Serum stimulation and Physiological stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 yo and older, with a loop ileostomy after colorectal surgery for malignant or benign disease and a barium enema that rules out colorectal anastomotic leak or stenosis.
- Patients must be self-sufficient in their stoma care or dispose of assistance by a family member or healthcare provider.
- Patients must reside no further than 50km from the hospital and dispose of postoperative home-assistance by a family member or healthcare provider.
Who cannot join
- Patients with a terminal ileostomy or a closed distal limb, inaccesible to preoperative stimulation.
- Patients with the diagnosis of inflammatory bowel disease.
- Patients incapable of comprehending or signing the informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The STIMIC Trial: A Multicenter Randomized Control Trial Evaluating the Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings
BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection. Temporary diversion of intestinal transit does not reduce the risk of anastomotic failure, but it does lower the morbidity and mortality associated with potential pelvic sepsis. Unfortunately, a second surgical procedure is required to restore intestinal continuity, and this carries its own risk of complications, the most common being postoperative ileus (temporary paralysis of bowel motility associated with abdominal distension, absence of bowel movements, nausea, and vomiting), which occurs in up to 20% of cases.
Several strategies have been proposed to reduce this problem, including stimulation of the efferent limb of the ileostomy (the part that is connected to the unused colon). This intervention consists of instilling a substance through the efferent limb of the ileostomy into the colon, simulating natural intestinal transit. It emerged as a harmless alternative aimed at reversing changes in the excluded colon in preparation for restoration of intestinal continuity. Several Spanish studies have investigated this technique, concluding that it is safe and significantly reduces the rate of postoperative ileus, thereby shortening hospital stay. Regarding the mechanism by which this intervention may be effective, there are studies investigating the changes that occur during diversion of intestinal transit:
Read more
- Histopathology: reduced muscular contractility and the presence of intestinal villi in the efferent intestinal limb and excluded colon, which improve once intestinal flow is restored.
- Microbiome: significant loss of microbiota in the defunctionalized colon, which progressively recovers with natural intestinal transit and reintroduction of a fiber-rich diet.
Structural and microbiota-related changes favor the development of diversion colitis, a condition associated with erratic bowel habits once intestinal transit is restored. In an attempt to reverse this condition, several products have been tested for stimulation of the efferent limb of the ileostomy: probiotics, short chain fatty acids, saline solution with a thickening agent, and the patient's own intestinal contents, a well-tolerated and effective technique, in some cases superior to saline-based alternatives.
Overall, the available evidence is of low quality due to the limited number of patients studied and protocol variability. For this reason, we propose the implementation of a protocol for stimulation of the distal ileostomy limb prior to ileostomy closure, either with saline solution and thickening agent (the most widely described technique in the literature) or physiological stimulation using the patient's own intestinal contents.
The protocol consists of several sessions in which the instilled volume is progressively increased. This intervention will be performed on an outpatient basis, once daily, during the two weeks prior to surgery.
This process promotes the onset of bowel movements through the anus, which progressively become more formed and less frequent, approaching a more normal bowel habit. Only minor adverse effects have been described with this technique, including cramp-like abdominal pain in 27.6% of sessions. Recently, a nationwide study confirmed the favorable clinical outcomes following distal ileostomy limb stimulation before ileostomy closure. However, to our knowledge, no studies have evaluated its effect on intestinal microbiota.
HYPOTHESIS Distal limb stimulation of the ileostomy before its closure helps in the recovery of the colorectal microbiome and tissue. This associates with lower postoperative complications, specially postoperative ileus.
OBJECTIVES To gain knowledge regarding changes in intestinal microbiota composition before and after stimulation, in order to better understand recovery of intestinal function following this procedure. We will also analyze outcomes after ileostomy closure following efferent limb stimulation, determining the incidence of postoperative complications, particularly postoperative ileus.
METHODOLOGY
Patients will be randomly assigned to one of three groups:
- Control (no intervention other than the usual preoperative protocol)
- Stimulation with serum and thickener
- Stimulation with own stoma output
Samples will be collected in all patients:
- Stoma output
- Stool, before stimulation, if performed
- Stool, after stimulation, if performed
- Stool, a month after surgery
For a group of patients, the ones recruited at Hospital Clínic, rectal biopsies will also be collected before and after stimulation, to compare the effect of the treatment in the colonic tissue. We will collect clinical data during the whole process regarding postoperative complications.
- Conditions
- Ileostomy Stoma, Stoma Stimulation, Microbiome Analysis
- Being tested
- Serum stimulation, Physiological stimulation
- Keywords
- efferent limb stimulation, ileostomy closure, colorectal microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum stimulationOther
Also called efferent limb stimulation, physiological stimulation
The intervention has been described in previous studies, but the investigation of the microbiome changes associated with the obtained clinical results hasn't been described to date. Also, a study with three arms hasn't been published to date.
Physiological stimulationOther
The intervention has been described in previous studies, but the investigation of the microbiome changes associated with the obtained clinical results hasn't been described to date. Also, a study with three arms hasn't been published to date.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No efferent limb stimulation. |
| Serum stimulation | Active comparator | Efferent limb stimulation with serum and thickener. Receives: Other: Serum stimulation |
| Physiological stimulation | Active comparator | Efferent limb stimulation with the patient's own stoma output. Receives: Other: Physiological stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in colorectal microbiome before and after efferent limb stimulation prior to stoma closure.
Descriptive analysis of the microbiome profiles of the three groups of patients (control, stimulation with serum, stimulation with own stoma output).
Measured: From enrollment to the end of follow-up at 3 months.
Changes in colorectal tissue before and after efferent limb stimulation prior to stoma closure.
Description of the tissue obtained by biopsy of the rectum, before and after stimulation of the ileostomy.
Measured: From the time of first biopsy (before stimulation) to the second one (surgery day).
Secondary outcomes (3)
Postoperative complications after stoma closure.
Incidence of postoperative ileus and surgical site infection.
Measured: From the surgery (ileostomy closure) to 30 days follow-up.
Functional outcomes after efferent limb stimulation (LARS score)
Description of the funcional (defecatory) outcomes after ileostomy closure.
LARS (Low Anterior Resection Syndrome) score: total score ranges from 0-42 points (0-20 is equivalent no LARS, 21-29 points to minor LARS, and 30-42 to major LARS).
Measured: From enrollment to the end of follow-up a 3 months.
Functional outcomes after efferent limb stimulation (Vaizey score)
Description of the funcional (defecatory) outcomes after ileostomy closure.
Vaizey score (also known as the St. Mark's Incontinence Score): total score ranges from 0 (perfect continence) to 24 points (severe incontinence).
Measured: From enrollment to the end of follow-up at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Ileostomy StomaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa
- Responsible party
- Principal investigator, Romina Pena, Hospital Clinic of Barcelona
- Investigators
- Romina Pena, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640113
- Sponsor's protocol ID
- HCB/2026/0615
- Acronym
- STIMIC
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Charbonneau J, Morin G, Pare XG, Frigault J, Drolet S, Bouchard A, Rouleau-Fournier F, Bouchard P, Thibault C, Letarte F. Loop Ileostomy Closure as a 23-Hour Stay Procedure With Preoperative Efferent Limb Enteral Stimulation: A Randomized Controlled Trial. Dis Colon Rectum. 2024 Mar 1;67(3):466-475. doi: 10.1097/DCR.0000000000003111. Epub 2023 Nov 16.
PubMed 37994456Bracey E, Chave H, Agombar A, Sleight S, Dukes S, Bryan S, Branagan G. Ileostomy closure in an enhanced recovery setting. Colorectal Dis. 2015 Oct;17(10):917-21. doi: 10.1111/codi.12989.
PubMed 25950922Kim MJ, Park JW, Lee MA, Lim HK, Kwon YH, Ryoo SB, Park KJ, Jeong SY. Two dominant patterns of low anterior resection syndrome and their effects on patients' quality of life. Sci Rep. 2021 Feb 11;11(1):3538. doi: 10.1038/s41598-021-82149-9.
PubMed 33574345Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
PubMed 17667498Arredondo J, Uriz A, Oliva I, Martin JI, Iglesias CN, Choolani E, Valle A, Rivera J, Jeri-McFarlane S, Romero JM, Gonzalez C, Alvarellos A, Tasende M, Gomez L, Lazaro L, Montcusi B, Tejedor P, Trujillo-Diaz J, de la Hermosa AR, Baixauli J, Nunez-Cordoba JM, Aliseda D; ILEOSTIM Trial Group. The ILEOSTIM trial: A multicentre randomised controlled trial evaluating the impact of efferent loop stimulation prior to ileostomy reversal on postoperative ileus. Colorectal Dis. 2026 May;28(5):e70448. doi: 10.1111/codi.70448.
PubMed 42092745Liu Z, Fang L, Lv L, Niu Z, Hou L, Chen D, Zhou Y, Guo D. Self-administered succus entericus reinfusion before ileostomy closure improves short-term outcomes. BMC Surg. 2021 Dec 28;21(1):440. doi: 10.1186/s12893-021-01444-4.
PubMed 34961502Xia F, Zou Y, Zhang Q, Wu J, Sun Z. A novel nomogram to predict low anterior resection syndrome (LARS) after ileostomy reversal for rectal cancer patients. Eur J Surg Oncol. 2023 Feb;49(2):452-460. doi: 10.1016/j.ejso.2022.10.015. Epub 2022 Oct 23.
PubMed 37406079Vogel I, Reeves N, Tanis PJ, Bemelman WA, Torkington J, Hompes R, Cornish JA. Impact of a defunctioning ileostomy and time to stoma closure on bowel function after low anterior resection for rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. 2021 Jul;25(7):751-760. doi: 10.1007/s10151-021-02436-5. Epub 2021 Apr 1.
PubMed 33792822Rombey T, Panagiotopoulou IG, Hind D, Fearnhead NS. Preoperative bowel stimulation prior to ileostomy closure to restore bowel function more quickly and improve postoperative outcomes: a systematic review. Colorectal Dis. 2019 Sep;21(9):994-1003. doi: 10.1111/codi.14636. Epub 2019 May 7.
PubMed 30963659Lloyd AJ, Hardy NP, Jordan P, Ryan EJ, Whelan M, Clancy C, O'Riordan J, Kavanagh DO, Neary P, Sahebally SM. Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis. Tech Coloproctol. 2023 Dec 14;28(1):15. doi: 10.1007/s10151-023-02875-2.
PubMed 38095756Rodriguez-Padilla A, Morales-Martin G, Perez-Quintero R, Gomez-Salgado J, Balongo-Garcia R, Ruiz-Frutos C. Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure. Nutrients. 2021 Feb 15;13(2):626. doi: 10.3390/nu13020626.
PubMed 33671968Ocana J, Garcia-Perez JC, Labalde-Martinez M, Rodriguez-Velasco G, Moreno I, Vivas A, Clemente-Esteban I, Ballestero A, Abadia P, Ferrero E, Fernandez-Cebrian JM, Die J. Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study. Tech Coloproctol. 2022 Aug;26(8):645-653. doi: 10.1007/s10151-022-02620-1. Epub 2022 May 21.
PubMed 35596903Fernandez Lopez F, Gonzalez Lopez J, Paz Novo M, Ladra Gonzalez MJ, Paredes Cotore J. Stimulation the efferent limb before loop ileostomy closure with short chain fatty acids. Cir Esp (Engl Ed). 2019 Jan;97(1):59-61. doi: 10.1016/j.ciresp.2018.06.018. Epub 2018 Oct 15. No abstract available. English, Spanish.
PubMed 30337046Garfinkle R, Demian M, Sabboobeh S, Moon J, Hulme-Moir M, Liberman AS, Feinberg S, Hayden DM, Chadi SA, Demyttenaere S, Samuel L, Hotakorzian N, Quintin L, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Boutros M; Bowel Stimulation Research Collaborative. Bowel stimulation before loop ileostomy closure to reduce postoperative ileus: a multicenter, single-blinded, randomized controlled trial. Surg Endosc. 2023 May;37(5):3934-3943. doi: 10.1007/s00464-022-09510-5. Epub 2022 Aug 19.
PubMed 35984521Abrisqueta J, Abellan I, Lujan J, Hernandez Q, Parrilla P. Stimulation of the efferent limb before ileostomy closure: a randomized clinical trial. Dis Colon Rectum. 2014 Dec;57(12):1391-6. doi: 10.1097/DCR.0000000000000237.
PubMed 25380005
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STIMIC Trial: A Multicenter Randomized Control Trial Evaluating the Impact of Ambulatory Physiological Stimulation of the Efferent Limb Prior to Ileostomy Closure on Colorectal Microbiota Composition and Histopathological Findings
- ClinicalTrials.gov ID
- NCT07640113
- Acronym / sponsor ID
- STIMIC / HCB/2026/0615
- Conditions
- Ileostomy Stoma, Stoma Stimulation, Microbiome Analysis
- Keywords
- efferent limb stimulation, ileostomy closure, colorectal microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Althaia Xarxa Assistencial Universitària de Manresa, Hospital Mutua de Terrassa
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 10 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.
BACKGROUND Loop ileostomies are a type of stoma frequently used to protect high-risk colorectal anastomoses (surgical reconnection of the intestines), for example following rectal cancer resection. Temporary diversion of intestinal transit does not reduce the risk of anastomotic failure, but it does lower the morbidity and mortality associated with potential pelvic sepsis. Unfortunately, a second surgical procedure is required to restore intestinal continuity, and this carries its own risk of complications, the most common being postoperative ileus (temporary paralysis of bowel motility associated with abdominal distension, absence of bowel movements, nausea, and vomiting), which occurs in up to 20% of cases.
Several strategies have been proposed to reduce this problem, including stimulation of the efferent limb of the ileostomy (the part that is connected to the unused colon). This intervention consists of instilling a substance through the efferent limb of the ileostomy into the colon, simulating natural intestinal transit. It emerged as a harmless alternative aimed at reversing changes in the excluded colon in preparation for restoration of intestinal continuity. Several Spanish studies have investigated this technique, concluding that it is safe and significantly reduces the rate of postoperative ileus, thereby shortening hospital stay. Regarding the mechanism by which this intervention may be effective, there are studies investigating the changes that occur during diversion of intestinal transit:
- Histopathology: reduced muscular contractility and the presence of intestinal villi in the efferent intestinal limb and excluded colon, which improve once intestinal flow is restored.
- Microbiome: significant loss of microbiota in the defunctionalized colon, which progressively recovers with natural intestinal transit and reintroduction of a fiber-rich diet.
Structural and microbiota-related changes favor the development of diversion colitis, a condition associated with erratic bowel habits once intestinal transit is restored. In an attempt to reverse this condition, several products have been tested for stimulation of the efferent limb of the ileostomy: probiotics, short chain fatty acids, saline solution with a thickening agent, and the patient's own intestinal contents, a well-tolerated and effective technique, in some cases superior to saline-based alternatives.
Overall, the available evidence is of low quality due to the limited number of patients studied and protocol variability. For this reason, we propose the implementation of a protocol for stimulation of the distal ileostomy limb prior to ileostomy closure, either with saline solution and thickening agent (the most widely described technique in the literature) or physiological stimulation using the patient's own intestinal contents.
The protocol consists of several sessions in which the instilled volume is progressively increased. This intervention will be performed on an outpatient basis, once daily, during the two weeks prior to surgery.
This process promotes the onset of bowel movements through the anus, which progressively become more formed and less frequent, approaching a more normal bowel habit. Only minor adverse effects have been described with this technique, including cramp-like abdominal pain in 27.6% of sessions. Recently, a nationwide study confirmed the favorable clinical outcomes following distal ileostomy limb stimulation before ileostomy closure. However, to our knowledge, no studies have evaluated its effect on intestinal microbiota.
HYPOTHESIS Distal limb stimulation of the ileostomy before its closure helps in the recovery of the colorectal microbiome and tissue. This associates with lower postoperative complications, specially postoperative ileus.
OBJECTIVES To gain knowledge regarding changes in intestinal microbiota composition before and after stimulation, in order to better understand recovery of intestinal function following this procedure. We will also analyze outcomes after ileostomy closure following efferent limb stimulation, determining the incidence of postoperative complications, particularly postoperative ileus.
METHODOLOGY
Patients will be randomly assigned to one of three groups:
- Control (no intervention other than the usual preoperative protocol)
- Stimulation with serum and thickener
- Stimulation with own stoma output
Samples will be collected in all patients:
- Stoma output
- Stool, before stimulation, if performed
- Stool, after stimulation, if performed
- Stool, a month after surgery
For a group of patients, the ones recruited at Hospital Clínic, rectal biopsies will also be collected before and after stimulation, to compare the effect of the treatment in the colonic tissue. We will collect clinical data during the whole process regarding postoperative complications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No efferent limb stimulation. |
| Serum stimulation | Active comparator | Other: Serum stimulationEfferent limb stimulation with serum and thickener. |
| Physiological stimulation | Active comparator | Other: Physiological stimulationEfferent limb stimulation with the patient's own stoma output. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 18 yo and older, with a loop ileostomy after colorectal surgery for malignant or benign disease and a barium enema that rules out colorectal anastomotic leak or stenosis.
- Patients must be self-sufficient in their stoma care or dispose of assistance by a family member or healthcare provider.
- Patients must reside no further than 50km from the hospital and dispose of postoperative home-assistance by a family member or healthcare provider.
Key exclusion criteria (3 listed)
- Patients with a terminal ileostomy or a closed distal limb, inaccesible to preoperative stimulation.
- Patients with the diagnosis of inflammatory bowel disease.
- Patients incapable of comprehending or signing the informed consent.
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 stimulationAlso: efferent limb stimulation, physiological stimulationThe intervention has been described in previous studies, but the investigation of the microbiome changes associated with the obtained clinical results hasn't been described to date. Also, a study with three arms hasn't been published to date. | Other | Serum stimulation |
| Physiological stimulationThe intervention has been described in previous studies, but the investigation of the microbiome changes associated with the obtained clinical results hasn't been described to date. Also, a study with three arms hasn't been published to date. | Other | Physiological stimulation |
Primary outcome
Changes in colorectal microbiome before and after efferent limb stimulation prior to stoma closure.
Time frame: From enrollment to the end of follow-up at 3 months.
Descriptive analysis of the microbiome profiles of the three groups of patients (control, stimulation with serum, stimulation with own stoma output).
Changes in colorectal tissue before and after efferent limb stimulation prior to stoma closure.
Time frame: From the time of first biopsy (before stimulation) to the second one (surgery day).
Description of the tissue obtained by biopsy of the rectum, before and after stimulation of the ileostomy.
3 secondary outcomes
Postoperative complications after stoma closure.
Time frame: From the surgery (ileostomy closure) to 30 days follow-up.
Functional outcomes after efferent limb stimulation (LARS score)
Time frame: From enrollment to the end of follow-up a 3 months.
Functional outcomes after efferent limb stimulation (Vaizey score)
Time frame: From enrollment to the end of follow-up at 3 months.
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 17 Jun 2026.
- Background: PubMed 37994456Charbonneau J, Morin G, Pare XG, Frigault J, Drolet S, Bouchard A, Rouleau-Fournier F, Bouchard P, Thibault C, Letarte F. Loop Ileostomy Closure as a 23-Hour Stay Procedure With Preoperative Efferent Limb Enteral Stimulation: A Randomized Controlled Trial. Dis Colon Rectum. 2024 Mar 1;67(3):466-475. doi: 10.1097/DCR.0000000000003111. Epub 2023 Nov 16.
- Background: PubMed 25950922Bracey E, Chave H, Agombar A, Sleight S, Dukes S, Bryan S, Branagan G. Ileostomy closure in an enhanced recovery setting. Colorectal Dis. 2015 Oct;17(10):917-21. doi: 10.1111/codi.12989.
- Background: PubMed 33574345Kim MJ, Park JW, Lee MA, Lim HK, Kwon YH, Ryoo SB, Park KJ, Jeong SY. Two dominant patterns of low anterior resection syndrome and their effects on patients' quality of life. Sci Rep. 2021 Feb 11;11(1):3538. doi: 10.1038/s41598-021-82149-9.
- Background: PubMed 17667498Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024.
- Background: PubMed 42092745Arredondo J, Uriz A, Oliva I, Martin JI, Iglesias CN, Choolani E, Valle A, Rivera J, Jeri-McFarlane S, Romero JM, Gonzalez C, Alvarellos A, Tasende M, Gomez L, Lazaro L, Montcusi B, Tejedor P, Trujillo-Diaz J, de la Hermosa AR, Baixauli J, Nunez-Cordoba JM, Aliseda D; ILEOSTIM Trial Group. The ILEOSTIM trial: A multicentre randomised controlled trial evaluating the impact of efferent loop stimulation prior to ileostomy reversal on postoperative ileus. Colorectal Dis. 2026 May;28(5):e70448. doi: 10.1111/codi.70448.
- Background: PubMed 34961502Liu Z, Fang L, Lv L, Niu Z, Hou L, Chen D, Zhou Y, Guo D. Self-administered succus entericus reinfusion before ileostomy closure improves short-term outcomes. BMC Surg. 2021 Dec 28;21(1):440. doi: 10.1186/s12893-021-01444-4.
- Background: PubMed 37406079Xia F, Zou Y, Zhang Q, Wu J, Sun Z. A novel nomogram to predict low anterior resection syndrome (LARS) after ileostomy reversal for rectal cancer patients. Eur J Surg Oncol. 2023 Feb;49(2):452-460. doi: 10.1016/j.ejso.2022.10.015. Epub 2022 Oct 23.
- Background: PubMed 33792822Vogel I, Reeves N, Tanis PJ, Bemelman WA, Torkington J, Hompes R, Cornish JA. Impact of a defunctioning ileostomy and time to stoma closure on bowel function after low anterior resection for rectal cancer: a systematic review and meta-analysis. Tech Coloproctol. 2021 Jul;25(7):751-760. doi: 10.1007/s10151-021-02436-5. Epub 2021 Apr 1.
- Background: PubMed 30963659Rombey T, Panagiotopoulou IG, Hind D, Fearnhead NS. Preoperative bowel stimulation prior to ileostomy closure to restore bowel function more quickly and improve postoperative outcomes: a systematic review. Colorectal Dis. 2019 Sep;21(9):994-1003. doi: 10.1111/codi.14636. Epub 2019 May 7.
- Background: PubMed 38095756Lloyd AJ, Hardy NP, Jordan P, Ryan EJ, Whelan M, Clancy C, O'Riordan J, Kavanagh DO, Neary P, Sahebally SM. Efferent limb stimulation prior to loop ileostomy closure: a systematic review and meta-analysis. Tech Coloproctol. 2023 Dec 14;28(1):15. doi: 10.1007/s10151-023-02875-2.
- Background: PubMed 33671968Rodriguez-Padilla A, Morales-Martin G, Perez-Quintero R, Gomez-Salgado J, Balongo-Garcia R, Ruiz-Frutos C. Postoperative Ileus after Stimulation with Probiotics before Ileostomy Closure. Nutrients. 2021 Feb 15;13(2):626. doi: 10.3390/nu13020626.
- Background: PubMed 35596903Ocana J, Garcia-Perez JC, Labalde-Martinez M, Rodriguez-Velasco G, Moreno I, Vivas A, Clemente-Esteban I, Ballestero A, Abadia P, Ferrero E, Fernandez-Cebrian JM, Die J. Can physiological stimulation prior to ileostomy closure reduce postoperative ileus? A prospective multicenter pilot study. Tech Coloproctol. 2022 Aug;26(8):645-653. doi: 10.1007/s10151-022-02620-1. Epub 2022 May 21.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
Romina Pena, MD principal investigator
Hospital Clinic of Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing Serum stimulation and Physiological stimulation in people with Ileostomy Stoma and Stoma Stimulation, run by Hospital Clinic of Barcelona.
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 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. 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?
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 Romina Pena, MD (+34 617333153, PENA@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in colorectal microbiome before and after efferent limb stimulation prior to stoma closure. (time frame: From enrollment to the end of follow-up at 3 months.). The study lists 2 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 NCT07640113, which also lists 20 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 17 Jun 2026.