Study for efficacy of DL-alanine

JRCT ID: jRCTs031230676

Registered date:05/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Primary sclerosing cholangitis
• Date of first enrollment: 05/03/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Taking 4g of DL-alanine (containing 2g DL-alanine) three time a day for 12 weeks.

Outcome(s)

• Primary Outcome: Percentage change of serum ALP levels

Secondary Outcome

1.Changes of serum ALP levels
2.Changes of serum gGTP, AST, ALT, TP, Alb, T-Bil, D-Bil, TC, AMY, Cr, UN, Glu, CRP, PT-INR, ESR,and LRG.
3.Changes of Child Pugh score and ALBI score.
4.Cumulative incidence rate of hospitalization and endoscopic intervention
5.Changes of Ulcerative colitis activity score; Mayo score, partial Mayo score, Lichtiger score.
6.Changes of quantification of fecal occult blood.
7.For the primary and secondary endpoints (1. and 2.), a historical cohort of patients with PSC who have attended our hospital in the past will be used for comparison.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients with PSC who meets all following conditions.
2.Patients within Child-Pugh score 6 during outpatient visits.
3.Serum alkaline phosphatase exceeds the upper limit of normal despite taking ursodeoxycholic acid (UDCA) 600 mg/day or more for 4 weeks.
4. Complicated with ulcerative colitis
5. Patients who are 20 years of age or older at the time of consent, and who have given their written consent.

• Exclude criteria: 1. Noncompensated liver cirrhosis with a Child Pugh classification of 7 or higher (B) 2. Common bile duct stones, severe bile duct stricture, or bacterial cholangitis requiring endoscopic intervention.3. Concomitant or pre-existing malignancy. 4. Ulcerative colitis classified as severe or fulminant. 5. History of adverse reaction or allergy to this reagent. 6. Patients with serious infectious diseases. 7. With serious cardiac disease. 8. With a serum creatinine level of 2.0 mg/dl or higher.9. Pregnant women or who may be pregnant, lactating, or wishing to become pregnant during the study period.10. Other patients deemed inappropriate for inclusion in the study by the investigator. 11.Exclusion criteria for concomitant medications. (1) Patients who have received antibiotic therapy within 2 weeks prior to enrollment. (2) Patients treated with steroids within 2 weeks prior to enrollment. (3) Patients who have been treated with biological agents for ulcerative colitis.(4) Patients may or may not have been treated with bezafibrate or 5-ASA.

Related Information

• Primary Sponsor: Nakamoto Nobuhiro