Ileostomy; ComplicationsPhase 3NCT05905393

The Protective Role of GABA Stimulation Before Ileostomy Closure

A Phase 3 study testing preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery and preoperative stimulation of the efferent loop with only physiological saline in people with Ileostomy; Complications, run by Qilu Hospital of Shandong University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The goal of this clinical trial is to explore whether preoperative stimulation of the distal limb of the ileostomy loop with gamma aminobutyric acid (GABA) could effectively reduce the incidence of complications after ileostomy closure. Participants will be divided into two groups. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ileostomy; Complications
What is being tested?: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery and preoperative stimulation of the efferent loop with only physiological saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: No sites listed yet
Study dates: Jun 2023to Dec 2024
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

over 18 years of age;
body mass index (BMI) 18.5-28 kg/m2;
having protective ileostomy after colorectal carcinoma surgery free of disease;
with endoscopic and histological confirmation of diversion colitis;
no oral antibiotics within 3 months;
having signed the informed consent.

Who cannot join

under 18 years of age;
clinical history, and histological confirmation of inflammatory bowel disease with colorectal involvement;
history of neoadjuvant or adjuvant chemoradiotherapy;
other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
serious perioperative complications such as anastomotic rupture after surgery;
oral antibiotics within three months;
participation in any other studies within the past 3 months.

Trial locations and contacts

No sites are listed yet.

Wei Guo, Dr. contact

0086-18560089725

wguo@sdu.edu.cn

Jiajia Mao, Dr. contact

0086-18560087976

805892561@qq.com

About this study

Official title: The Protective Role of Preoperative Stimulation of the Distal Limb of the Ileostomy Loop With GABA Before Ileostomy Closure

Participants will be divided into two groups. One group included patients treated with stimulation of the efferent loop with GABA prior to transit reconstruction surgery; the other control group was stimulated without giving any substance.

Researchers will compare incidence of complications such as postoperative ileus, diarrhea and other parameters such as time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay, etc.

Conditions: Ileostomy; Complications
Being tested: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery, preoperative stimulation of the efferent loop with only physiological saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

preoperative stimulation of the efferent loop with GABA before ileostomy closure surgeryDietary supplement
Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline.
preoperative stimulation of the efferent loop with only physiological salineDietary supplement
Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of 100 ml of 0.9% physiological saline.

Study groups in NCT05905393
Study group	Role	What they receive
preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery	Experimental	Preoperative stimulation of the distal limb of the ileostomy loop with GABA was performed during the 5 days prior to surgery every day. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool. Sterile Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline. Each preparation was made under sterile conditions and maintaining the cold chain. Receives: Dietary Supplement: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
control group was stimulated without giving any substance	Sham comparator	Control group was stimulated without giving any substance. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool. After 5 stimulation sessions, reconstructive surgery was performed within the following 24 h. Receives: Dietary Supplement: preoperative stimulation of the efferent loop with only physiological saline

What is being measured

The primary outcome is the main question the study is designed to answer.

incidence of complications after ileostomy closure
postoperative ileus, diarrhea, time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay.
Measured: From date of randomization until the date of discharge, assessed up to 20 days

Secondary outcomes (3)

glucose metabolism-related parameters
Insulin, C peptide
Measured: From date of randomization until the date of discharge, assessed up to 20 days
microbiota alteration
microbiota alteration before and after GABA stimulation
Measured: From date of randomization until the date of discharge, assessed up to 20 days
metabolite alteration
metabolite alteration before and after GABA stimulation
Measured: From date of randomization until the date of discharge, assessed up to 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2023Dec 2024

First posted15 Jun 2023
Study startJun 2023 (estimated)
Primary completionJun 2024 (estimated)
Study completionDec 2024 (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 Ileostomy; ComplicationsStudies of the same condition, open and under way.
More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05905393
Sponsor's protocol ID: KYLL-202212-066-1
Status last verified: Jun 2023
First submitted: 30 May 2023
Last updated: 15 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Strandwitz P, Kim KH, Terekhova D, Liu JK, Sharma A, Levering J, McDonald D, Dietrich D, Ramadhar TR, Lekbua A, Mroue N, Liston C, Stewart EJ, Dubin MJ, Zengler K, Knight R, Gilbert JA, Clardy J, Lewis K. GABA-modulating bacteria of the human gut microbiota. Nat Microbiol. 2019 Mar;4(3):396-403. doi: 10.1038/s41564-018-0307-3. Epub 2018 Dec 10.
PubMed 30531975
Rodriguez-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 33671968
Bansal P, Wang S, Liu S, Xiang YY, Lu WY, Wang Q. GABA coordinates with insulin in regulating secretory function in pancreatic INS-1 beta-cells. PLoS One. 2011;6(10):e26225. doi: 10.1371/journal.pone.0026225. Epub 2011 Oct 21.
PubMed 22031825
Soltani N, Qiu H, Aleksic M, Glinka Y, Zhao F, Liu R, Li Y, Zhang N, Chakrabarti R, Ng T, Jin T, Zhang H, Lu WY, Feng ZP, Prud'homme GJ, Wang Q. GABA exerts protective and regenerative effects on islet beta cells and reverses diabetes. Proc Natl Acad Sci U S A. 2011 Jul 12;108(28):11692-7. doi: 10.1073/pnas.1102715108. Epub 2011 Jun 27.
PubMed 21709230
Garfinkle R, Savage P, Boutros M, Landry T, Reynier P, Morin N, Vasilevsky CA, Filion KB. Incidence and predictors of postoperative ileus after loop ileostomy closure: a systematic review and meta-analysis. Surg Endosc. 2019 Aug;33(8):2430-2443. doi: 10.1007/s00464-019-06794-y. Epub 2019 Apr 17.
PubMed 31020433
Matthiessen 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 17667498
Wang S, Xiang YY, Zhu J, Yi F, Li J, Liu C, Lu WY. Protective roles of hepatic GABA signaling in acute liver injury of rats. Am J Physiol Gastrointest Liver Physiol. 2017 Mar 1;312(3):G208-G218. doi: 10.1152/ajpgi.00344.2016. Epub 2016 Dec 15.
PubMed 27979827
Wang S, Sui S, Liu Z, Peng C, Liu J, Luo D, Fan X, Liu C, Lu WY. Protective roles of hepatic gamma-aminobutyric acid signaling in acute ethanol exposure-induced liver injury. J Appl Toxicol. 2018 Mar;38(3):341-350. doi: 10.1002/jat.3544. Epub 2017 Oct 17.
PubMed 29044621
Beamish EL, Johnson J, Shaw EJ, Scott NA, Bhowmick A, Rigby RJ. Loop ileostomy-mediated fecal stream diversion is associated with microbial dysbiosis. Gut Microbes. 2017 Sep 3;8(5):467-478. doi: 10.1080/19490976.2017.1339003. Epub 2017 Jun 16.
PubMed 28622070
Rombey 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 30963659

Want to know more?

Wei Guo, Dr.

0086-18560089725

wguo@sdu.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Colorectal Surgery, Colorectal Cancer
Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Rectal Cancer, Low Anterior Resection Syndrome

All Ileostomy; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Protective Role of Preoperative Stimulation of the Distal Limb of the Ileostomy Loop With GABA Before Ileostomy Closure
ClinicalTrials.gov ID: NCT05905393
Acronym / sponsor ID: KYLL-202212-066-1
Conditions: Ileostomy; Complications
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Qilu Hospital of Shandong UniversityUniversity, hospital or other
Study start: Jun 2023 (estimated)
Primary completion: Jun 2024 (estimated)
Study completion: Dec 2024 (estimated)
First posted: 15 Jun 2023 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery	Experimental	Dietary Supplement: preoperative stimulation of the efferent loop with GABA before ileostomy closure surgeryPreoperative stimulation of the distal limb of the ileostomy loop with GABA was performed during the 5 days prior to surgery every day. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool. Sterile Foley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline. Each preparation was made under sterile conditions and maintaining the cold chain.
control group was stimulated without giving any substance	Sham comparator	Dietary Supplement: preoperative stimulation of the efferent loop with only physiological salineControl group was stimulated without giving any substance. During the process and after it, the patient himself registers the appearance of symptoms after each stimulation session: abdominal pain, emission of gas and stool. After 5 stimulation sessions, reconstructive surgery was performed within the following 24 h.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

over 18 years of age;
body mass index (BMI) 18.5-28 kg/m2;
having protective ileostomy after colorectal carcinoma surgery free of disease;
with endoscopic and histological confirmation of diversion colitis;
no oral antibiotics within 3 months;

Key exclusion criteria (7 listed)

under 18 years of age;
clinical history, and histological confirmation of inflammatory bowel disease with colorectal involvement;
history of neoadjuvant or adjuvant chemoradiotherapy;
other serious chronic diseases, such as cardiovascular and cerebrovascular diseases, diabetes, respiratory diseases, etc;
serious perioperative complications such as anastomotic rupture after surgery;

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
preoperative stimulation of the efferent loop with GABA before ileostomy closure surgeryFoley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of a solution with 3000 mg of GABA diluted in 100 ml of 0.9% physiological saline.	Dietary supplement	preoperative stimulation of the efferent loop with GABA before ileostomy closure surgery
preoperative stimulation of the efferent loop with only physiological salineFoley catheter No.14 Ch connected to an infusion set was introduced through the defunctioned bowel to allow the slow infusion, for 10-20 minutes, of 100 ml of 0.9% physiological saline.	Dietary supplement	control group was stimulated without giving any substance

Primary outcome

incidence of complications after ileostomy closure
Time frame: From date of randomization until the date of discharge, assessed up to 20 days
postoperative ileus, diarrhea, time to tolerating a diet, start of the passage of flatus, start of the passage of stool, postoperative stay.

3 secondary outcomes

glucose metabolism-related parameters
Time frame: From date of randomization until the date of discharge, assessed up to 20 days
microbiota alteration
Time frame: From date of randomization until the date of discharge, assessed up to 20 days
metabolite alteration
Time frame: From date of randomization until the date of discharge, assessed up to 20 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
Background: PubMed 30531975Strandwitz P, Kim KH, Terekhova D, Liu JK, Sharma A, Levering J, McDonald D, Dietrich D, Ramadhar TR, Lekbua A, Mroue N, Liston C, Stewart EJ, Dubin MJ, Zengler K, Knight R, Gilbert JA, Clardy J, Lewis K. GABA-modulating bacteria of the human gut microbiota. Nat Microbiol. 2019 Mar;4(3):396-403. doi: 10.1038/s41564-018-0307-3. Epub 2018 Dec 10.
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 22031825Bansal P, Wang S, Liu S, Xiang YY, Lu WY, Wang Q. GABA coordinates with insulin in regulating secretory function in pancreatic INS-1 beta-cells. PLoS One. 2011;6(10):e26225. doi: 10.1371/journal.pone.0026225. Epub 2011 Oct 21.
Background: PubMed 21709230Soltani N, Qiu H, Aleksic M, Glinka Y, Zhao F, Liu R, Li Y, Zhang N, Chakrabarti R, Ng T, Jin T, Zhang H, Lu WY, Feng ZP, Prud'homme GJ, Wang Q. GABA exerts protective and regenerative effects on islet beta cells and reverses diabetes. Proc Natl Acad Sci U S A. 2011 Jul 12;108(28):11692-7. doi: 10.1073/pnas.1102715108. Epub 2011 Jun 27.
Background: PubMed 31020433Garfinkle R, Savage P, Boutros M, Landry T, Reynier P, Morin N, Vasilevsky CA, Filion KB. Incidence and predictors of postoperative ileus after loop ileostomy closure: a systematic review and meta-analysis. Surg Endosc. 2019 Aug;33(8):2430-2443. doi: 10.1007/s00464-019-06794-y. Epub 2019 Apr 17.
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 27979827Wang S, Xiang YY, Zhu J, Yi F, Li J, Liu C, Lu WY. Protective roles of hepatic GABA signaling in acute liver injury of rats. Am J Physiol Gastrointest Liver Physiol. 2017 Mar 1;312(3):G208-G218. doi: 10.1152/ajpgi.00344.2016. Epub 2016 Dec 15.
Background: PubMed 29044621Wang S, Sui S, Liu Z, Peng C, Liu J, Luo D, Fan X, Liu C, Lu WY. Protective roles of hepatic gamma-aminobutyric acid signaling in acute ethanol exposure-induced liver injury. J Appl Toxicol. 2018 Mar;38(3):341-350. doi: 10.1002/jat.3544. Epub 2017 Oct 17.
Background: PubMed 28622070Beamish EL, Johnson J, Shaw EJ, Scott NA, Bhowmick A, Rigby RJ. Loop ileostomy-mediated fecal stream diversion is associated with microbial dysbiosis. Gut Microbes. 2017 Sep 3;8(5):467-478. doi: 10.1080/19490976.2017.1339003. Epub 2017 Jun 16.
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.
Individual participant dataSharing planned: Undecided

Related trials for Ileostomy; Complications

Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Not yet recruiting
Phasix Mesh Underlay During Loop Ileostomy Closure
Incisional Hernia of Anterior Abdominal Wall
Recruiting
Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy
Colorectal Surgery, Colorectal Cancer
Active, not recruiting
Autologous Fecal Microbiota Transplantation for Anal Function Recovery After Ileostomy Reversal in Rectal Cancer
Rectal Cancer, Low Anterior Resection Syndrome

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.

Wei Guo, Dr. contact

0086-18560089725

wguo@sdu.edu.cn

Jiajia Mao, Dr. contact

0086-18560087976

805892561@qq.com

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wei Guo, Dr. (0086-18560089725, wguo@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidence of complications after ileostomy closure (time frame: From date of randomization until the date of discharge, assessed up to 20 days). 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 NCT05905393, 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 15 Jun 2023.