Randomized trial for the prevention of high-output stoma after ileostomy formation

Randomized trial for the prevention of high-output stoma after ileostomy formation - Prevention of High-Output Stoma trial (PHOS trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000035457

Enrollment

Registered

2019-03-23

Start date

2019-03-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal disease

Interventions

Oral administration test drug (Goreisan) 7.5g (2.5g/pack*3 packs) before meals and test drug (BIO-THREE) 3g (1g/tab*3 tabs) after meals. Oral administration test drug (BIO-THREE) 3g (1g/tab*3 tabs) af

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients received surgery with ileostomy for colorectal disease 2)Patients who can orally administration

Exclusion criteria

Exclusion criteria: 1)Patients with severe comorbidity 2)Patients with organ dysfunction 3)Patients requiring emergency surgery 4)Patients with Stage IV colorectal cancer

Design outcomes

Primary

Measure	Time frame
rehydration	—

Secondary

Measure	Time frame
Age, gender, comorbidity (eg, diabetes mellitus), short bowel, intra-abdominal sepsis, enteritis (eg, clostridium), recurrent disease in the remaining bowel (eg, Ulcerative colitis or Crohn's disease), sudden cessation of drugs (eg, steroids or opiates), administration of prokinetics (eg, metoclopramide), preoperative chemotherapy, preoperative radiotherapy, Body weight change (Total body water), treatment of electrolyte disturbance, daily stoma output (ml/day), evaluation of the symptoms such as nausea, headache, fatigue, anorexia, abdominal pain (VAS score), assessment of the peristomal inflammation, hospital stay, rate of readmission	—

Measure

Time frame

Age, gender, comorbidity (eg, diabetes mellitus), short bowel, intra-abdominal sepsis, enteritis (eg, clostridium), recurrent disease in the remaining bowel (eg, Ulcerative colitis or Crohn's disease), sudden cessation of drugs (eg, steroids or opiates), administration of prokinetics (eg, metoclopramide), preoperative chemotherapy, preoperative radiotherapy, Body weight change (Total body water), treatment of electrolyte disturbance, daily stoma output (ml/day), evaluation of the symptoms such as nausea, headache, fatigue, anorexia, abdominal pain (VAS score), assessment of the peristomal inflammation, hospital stay, rate of readmission

—

Countries

Japan

Contacts

Public ContactHiroki Hamamoto

Osaka Medical and Pharmaceutical University Department General and Gastroenterological Surgery

hiroki.hamamoto@ompu.ac.jp072-683-1221

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026