The Impact of Probiotic Intervention on the Gut Microbiota and Bowel Function

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHuashan Hospital

About this trial

This study aims to propose a novel, easy-to-operate intervention strategy that effectively improves defecation function after stoma reversal and to assess its impact on the gut microbiota.The efficacy and safety of antegrade placement of probiotics into the distal deserted intestine during prophylactic stoma to improve bowel function after stoma reversal were evaluated through randomized controlled clinical trials.Observing the changes in gut microbiota during the prophylactic stoma period, the impact of probiotics on the structure of gut microbiota, and exploring the correlation between gut genera and bowel function after stoma reversal.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years

Ultra low rectal cancer meeting the indication for Intersphincteric Resection (ISR) surgery

Underwent a prophylactic ileostomy

Scheduled for stoma reversal surgery within 6 months after the ISR procedure

Disqualifiers

Does not meet the surgical indications for Intersphincteric Resection (ISR)

Presence of multiple primary colorectal malignancies

Patients who have received neoadjuvant radiotherapy

Patients who experience disease progression or death in the postoperative period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clostridium butyricum (live) Tablets(Meiya)

    Biological/Vaccine

    Clostridium butyricum (live) Tablet administered into the dysfunctional intestine for low dose and high dose group, while control group has no intervention

Treatment groups

156 Participants
are divided into 3 treatment groups
Group A: high dose groupExperimental treatment 1 intervention
Group B: low dose groupExperimental treatment 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Low Anterior Resection Syndrome Score(LARS Score)

Comparison of LARS scores among the three groups at one month postoperatively. Low Anterior Resection Syndrome (LARS) is characterized by major symptoms including difficulty defecating, urgency, incontinence of liquid stool, incontinence of flatus, and increased frequency of bowel movements. Based on severity, LARS can be classified as none (0-20 points), minor (21-29 points), or major (30-42 points) using LARS score. And higher scores mean a worse outcome.

Time frame
One month after stoma reversal
2

microbial diversity

Fecal samples from study participants with ISR preoperatively and postoperatively will be collected to analyze the alpha and beta diversity of gut microbiota among the three groups

Time frame
The first stool sample will be collected within one week before ISR surgery, and the second stool sample will be collected within three to five days after stoma reversal, upon the first bowel movement.

Secondary outcomes

1

Wexner Incontinence Score

The Wexner Incontinence Score (WIS) assesses the severity of incontinence from five aspects: solid stool incontinence, liquid stool incontinence, flatus incontinence, pad usage, and lifestyle alterations. The score ranges from 0 to 20, where 0 represents normal and 20 represents complete incontinence.

Time frame
one month after ISR
2

Kirwan Incontinence Score

This grading system classifies anal incontinence into five grades (I-V) based on symptom severity: Grade I: No incontinence; Grade II: Incontinence to flatus or liquid stool; Grade III: Occasional solid stool incontinence; Grade IV: Frequent solid stool incontinence; Grade V: Requires a stoma (fecal diversion). Among these, Grades I-II indicate good continence function, while Grades III-IV indicate poor continence function.

Time frame
one month after ISR
3

Exploratory LARS Scoring Instrument

An exploratory scoring instrument was used to determine the severity of 16 specific variables that were identified by the Delphi consensus for defining LARS. In accordance with the response range defined by the WIS, there were 5 frequency options ranging from never (meaning no episodes; score 0) to always (meaning 1 or more episodes/day; score 4) for each item. Given that social and psychological features (marital separation, divorce, widowed seniors, etc) may have an influence on "relationships and intimacy," its response category for "never" was replaced with dichotomous options of "none" and "N/A." The summary score, also called the Delphi consensus severity score, was used as an index for patient-reported severity of LARS, ranging from 0 (best) to 64 (worst).

Time frame
one month after ISR
4

Fecal Incontinence Quality of Life (FIQL) Scale

The Fecal Incontinence Quality-of-Life (FIQL) Scale was used to analyze CSQoL. The FIQL entails 29 items that cover 4 domains: lifestyle (10 items), coping/behavior (9 items), depression/self-perception (7 items), and embarrassment (3 items).19 Each item has a range of 1 to 4 (except 2 items in depression/self-perception with ranges of 1-5 and 1-6). The score for each domain is the average of all items within its domain, and the global score is the mean of all domains. Higher scores indicate better CSQoL.

Time frame
one month after ISR

Other outcomes

Sponsors and contacts

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Huashan Hospital

Lead sponsor

Characteristic Medical Center of Rocket Army

Collaborator

Zhongnan Hospital

Collaborator

The First Affiliated Hospital of Nankai University

Collaborator

First Affiliated Hospital of Fujian Medical University

Collaborator

Ruijin Hospital

Collaborator

Nanfang Hospital, Southern Medical University

Collaborator