臨床研究等提出・公開システム

Study for efficacy of DL-alanine in patients with primary sclerosing cholangitis (Study for efficacy of DL-alanine)

Study for efficacy of DL-alanine

Nakamoto Nobuhiro

Keio University School of Medicine

35 Shinanomachi, Shinjuku-ku, Tokyo

nobuhiro.z2@keio.jp

Nakadai Yukie

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-5843-7090

yukie-t.1223@keio.jp

Recruiting

Mar. 05, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Primary sclerosing cholangitis

Taking 4g of DL-alanine (containing 2g DL-alanine) three time a day for 12 weeks.

Cholangitis, Sclerosing

Percentage change of serum ALP levels

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.

+81-3-5363-3503

Mar. 04, 2024

No

none