| 基本情報/Basic information |
| 一般向け試験名/Public title |
内視鏡的食道静脈瘤治療期間の食事制限状態に対するBCAA顆粒製剤と経腸栄養剤とBCAA高含有経腸栄養剤との栄養改善効果比較試験 |
Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices. |
| 一般向け試験名略称/Acronym |
内視鏡的食道静脈瘤治療期間のBCAA顆粒製剤と経腸栄養剤とBCAA高含有経腸栄養剤との栄養改善効果比較試験 |
Controlled comparative study for nutritional improvement among BCAA,general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices. |
| 科学的試験名/Scientific Title |
内視鏡的食道静脈瘤治療期間の食事制限状態に対するBCAA顆粒製剤と経腸栄養剤とBCAA高含有経腸栄養剤との栄養改善効果比較試験 |
Controlled comparative study for nutritional improvement among branched chain amino acids(BCAA),general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices. |
| 科学的試験名略称/Scientific Title:Acronym |
内視鏡的食道静脈瘤治療期間のBCAA顆粒製剤と経腸栄養剤とBCAA高含有経腸栄養剤との栄養改善効果比較試験 |
Controlled comparative study for nutritional improvement among BCAA,general liquid nutrient and BCAA-rich nutrient during endscopic treatment of esophageal varices. |
| 試験実施地域/Region |
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| 評価/Assessment |
| 主要アウトカム評価項目/Primary outcomes |
①間接カロリー計を用いた栄養代謝改善度
観察開始時をday０とし、内視鏡治療をday０、７、１４に行う。各々の治療日に間接カロリー計にてnpRQの改善度を検討する。
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1.The rate of improvement in nutritional metabolism using indirect calorimetry
The starting date of study is defined as day0, and endscopic therapies are conducted on day0,day7 and day14. The rate of improvement in non-protein respiratory quotient(npRQ) using indirect calorimetry are evaluated every therapic day.
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| 副次アウトカム評価項目/Key secondary outcomes |
①主観的包括的評価改善度
day０、７、１４、５６に問診による自覚症状や身体計測を中心として変動を評価する。
②血清蛋白変動
day０、７、１４、５６における血清アルブミン値、プレアルブミン値、レチノール酸結合蛋白(RBP)値、総分岐鎖アミノ酸／チロシンモル比(BTR)の変動を評価する。
③耐糖能変動
day０、７、１４、５６に早朝空腹時血糖、インスリン値を測定し耐糖能変動を評価する。
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1.The rate of improvement by Subjective Global Assessment
The rate of improvements in subjective symptom and physical measurement are evaluated on day0,day7,day14,and day56.
2.The transition of serum protein
The transitional changes of serum albumin, pre-albumin, retinol-binding protein(RBP), branched chain amino acid & tyrosine ratio(BTR) are evaluated on day0,day7,day14,and day56.
3.The changes of glucose tolerance
Glucose tolerance in fasting blood sugar,immunoreactive insulin(IRI) are evaluated on day0,day7,day14,and day56
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| 介入/Intervention |
| 群数/No. of arms |
5 |
| 介入の目的/Purpose of intervention |
治療・ケア/Treatment |
| 介入の種類/Type of intervention |
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| 介入1/Interventions/Control_1 |
試験開始前にBCAA製剤が未投与の患者において。治療後開始後より治療終了まで通常食のみ。治療終了後も内服なし。 |
Patients without BCAA before this study.
This group reseives no additional nutrient during whole period of this study.(GroupA)
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| 介入2/Interventions/Control_2 |
試験開始前にBCAA製剤が未投与の患者において。経腸栄養剤(ラコール)を1日２パック(朝、眠前)、治療開始後より治療終了まで服用。治療終了後は内服なし。 |
Patients without BCAA before this study.
This group reseives two packs of a general liquid nutrient(Racol) per day in two divided breakfast and bedtime during first 14days.Thereafter,no additional nutrient is administered till the end of this study.(GroupB)
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| 介入3/Interventions/Control_3 |
試験開始前にBCAA製剤が未投与の患者において。BCAA高含有経腸栄養剤(アミノレバンEN)を1日２包(朝、眠前)、治療開始後より治療終了まで服用。治療終了後は BCAA高含有経腸栄養剤(アミノレバンEN)を1日１包(眠前)、6週間内服。 |
Patients without BCAA before this study.
This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and one pack per day in one divided bedtime next 42days.(GroupC)
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| 介入4/Interventions/Control_4 |
試験開始前にBCAA製剤が投与されている患者において。BCAA製剤(リーバクト)を1日３包(朝1包、眠前２包)、治療開始後より治療終了まで服用。治療終了後はBCAA製剤(リーバクト)を1日3包(朝、昼、夕)、6週間内服。 |
Patients with BCAA before this study.
This group reseives three packs of a BCAA(Livact) per day in two divided breakfast and bedtime during first 14days,and three pack per day in three divided breakfast lunch dinner next 42days.(GroupD)
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| 介入5/Interventions/Control_5 |
試験開始前にBCAA製剤が投与されている患者において。BCAA高含有経腸栄養剤(アミノレバンEN)を1日２包(朝、眠前)、治療開始後より治療終了まで通常食に加え服用。治療終了後もBCAA高含有経腸栄養剤(アミノレバンEN)を1日２包(朝、眠前)、6週間内服。 |
Patients with BCAA before this study.
This group reseives two packs of a BCAA-rich nutrient(AminolebanEN) per day in two divided breakfast and bedtime during first 14days,and next 42days.(GroupE)
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| 介入6/Interventions/Control_6 |
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| 介入7/Interventions/Control_7 |
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| 介入8/Interventions/Control_8 |
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| 介入9/Interventions/Control_9 |
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| 介入10/Interventions/Control_10 |
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| 適格性/Eligibility |
| 年齢（下限）/Age-lower limit |
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| 年齢（上限）/Age-upper limit |
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| 性別/Gender |
男女両方/Male and Female |
| 選択基準/Key inclusion criteria |
①内視鏡的食道静脈瘤治療患者。
②本研究の内容を理解し、文書により研究参加の同意が本人より得られる患者。
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1.patients with esophageal varices who will receive endscopic therapy.
2.patients who understand the study contents and give informed consents by themselves.
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| 除外基準/Key exclusion criteria |
①アルブミン製剤を定期的(週に1回以上、一か月以上継続)に投与している患者。
②著しい糖代謝異常を呈する患者。
③腎不全を合併する患者。
④先天性アミノ酸異常のある患者。
⑤その他、担当医師が不適当と判断した患者。
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1.patients who took regular administration of albumin products more than once a week for one month.
2.patients with severe disorder of glucose metabolism.
3.patients with severe renal failure.
4.patients with congenital disorder of amino-acid metabolism.
5.patients who are regarded in-eligible by the doctor who participates in this study.
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| 目標参加者数/Target sample size |
100 |
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