Double blind clinical trial on a lactose-free and a lactose-containing formula in the treatment of acute diarrhea in children

Main Article Content

Sri Lestari
Agus Firmansyah
Zakiudin Munasir

Abstract

Background Lactose intolerance is a common complication of
diarrhea in young children particularly that due to rotaviral infec-
tion. A meta-analysis study evaluated the use of undiluted lactose
containing formula or cow’s milk during an episode of diarrhea. It
was concluded that routine dilution of milk and the use of lactose-
free milk formula are not necessary.
Objective To evaluate the effect of lactose free formula compared
with lactose-containing milk formula during acute diarrheal episode
in outpatient setting.
Methods A total of 56 children with acute diarrhea with mild-mod-
erate or no dehydration attending to the outpatient clinic were ran-
domly assigned to receive a lactose-free formula (Nestle Nan ® free
lactose) or lactose-containing milk formula (Nestle Nan 2 ® formula)
after initial rehydration. Comparisons of stool frequency, duration
of diarrhea and treatment failure rates were noted. Treatment fail-
ure was defined as clinical requirement for intravenous infusion
after rehydration or prolonged diarrhea (>7 days).
Results The duration of diarrhea was similar between the two
groups (P=0.195) in spite of two children who received lactose
free formula did not resolve from diarrhea within 7 days of treat-
ment. The median of stool frequency was indifferent in the two
groups (P=0.199) in rotavirus gastroenteritis; there were no differ-
ences in the duration of diarrhea or the stool frequency.
Conclusion Children without dehydration or with mild dehydra-
tion tolerated to lactose-containing formula as well as lactose-free
formula for the treatment of acute diarrhea

Article Details

How to Cite
1.
Lestari S, Firmansyah A, Munasir Z. Double blind clinical trial on a lactose-free and a lactose-containing formula in the treatment of acute diarrhea in children. PI [Internet]. 18Oct.2016 [cited 25Jul.2021];46(6):271-. Available from: https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/956
Section
Articles
Author Biographies

Sri Lestari

Department of Child Health, Medical School, University of
Indonesia, Jakarta, Indonesia.

Agus Firmansyah

Department of Child Health, Medical School, University of
Indonesia, Jakarta, Indonesia.

Zakiudin Munasir

Department of Child Health, Medical School, University of
Indonesia, Jakarta, Indonesia.
Received 2016-10-17
Accepted 2016-10-17
Published 2016-10-18

References

1. WHO. Major causes of death among children under
five world wide 2001. Available from URL: www.
who.int/child-adolescent-health/overview/child-
health/ map00world.jpg.andmap01world.jpg.
2. Afifah T, Djaja Sarimawar, Irianto Joko. Kecenderungan
penyakit penyebab kematian bayi dan anak balita di Indo-
nesia: 1992-2001. Bul Penel Kesehatan 2003;31 :48-59.
3. Firmansyah A. Kontroversi mengenai formula rendah
dan bebas laktosa dalam tata laksana diare pada anak.
Maj Kes Masy Indones 2002;1:27-35.
4. Lebenthal E, Kretchmer N, Alliet P. Lactase deficiency, lac-
tose malabsorption and lactose intolerance. In: Lebenthal
E, editor. Textbook of gastroenterology and nutrition in
infancy. New York: Raven Press; 1989. p. 459-72.
5. Departemen Kesehatan RI. Epidemiologi dan etiologi
diare. In: Ditjen PPM & PLP Departemen Kesehatan,
editor. Buku ajar diare. Jakarta: Depkes; 1999. p. 3-14.
6. Frye RE. Diarrhea. Available from http://www.
emedicine.com.
7. Suharjono, Sunoto, Sutedjo. Lactose intolerance in In-
donesian children. Ann Inst Child Health 1971;1:7.
8. Hegar B, Firmansyah A. Evaluasi penderita diare yang
dirawat di bangsal anak RSCM 1994. Maj Kes Masy
Indones 1995;8:563-5.
9. Brown KH, Reerson JM, Fontaine O. Use of nonhu-
man milks in the dietary management of young chil-
dren with acute diarrhoea: A meta-analysis of clinical
trials. Pediatrics 1994;93:17-27.
10. Madiyono B, Mz Moeslichan S, Sastroasmoro S,
Budiman I, Purwanto HS. Perkiraan besar sampel. In:
Sastroasmoro S, Ismael S, editors. Dasar-dasar
metodologi penelitian klinis. 2nd ed. Jakarta: CV
Sagung Seto; 2002. p. 259-86.
11. World Health Organization. The treatment of diarrhea:
Amanual for physicians and other senior health work-
ers. WHO/CDD/SER/80.2 rev.3. Geneva, Switzerland:
World Health Organization, 1995.
12. Ariani A. Gambaran diare akut serta hubungannya
dengan gejala yang ditemukan pada anak 0-2 tahun
yang dirawat di SMF anak RSUPNCM periode Sep-
tember 1996-Januari 1997 [thesis]. Jakarta: Bagian
Patologi Klinik FKUI, 1998.
13. Tjitrasari T, Firmansyah A, Chair I. Clinical manifes-
tations of rotavirus diarrhea in the outpatient clinic of
Cipto Mangunkusumo Hospital, Jakarta. Pediatr
Indones 2005;45:69-75.
14. DuPont HL, Miranda AG. Small intestine: Infectious
with common bacterial and viral pathogens. In: Yamada
T, Alpers DH, Powell DW, Owyang C, Silverstein EE,
editors. Textbook of gastroenterology. 2nd ed. Phila-
delphia: JB Lippincott; 1995. p. 1605-29.
15. Santoshan M, Foster S, Reid R, Bertrando R, Yolken
R, Burns B, et al. Role of soy-based, lactose-free for-
mula during treatment of acute diarrhea. Pediatrics
1985;76:292-8.
16. Khin-Maung-U, Nyunt-Nyunt-Wai, Myo-Khin, Mu-
Mu-Khin, Tin-U, Thane-Toe. Effect of clinical outcome
of breast feeding during acute diarrhea. British Medi-
cal Journal 1985;290:587-9.
17. Faruque AS, Mahalabis D, Islam A, Haque SS, Hasnat
A. Breast feeding and oral rehydration at home during
diarrhea to prevent dehydration. Arch Dis Child
1992;67:1027-9.
18. Haffejee IE. Cow’s milk-based formula, human milk,
and soy feeds in acute infantile diarrhea: A thera-
peutic trial. J Pediatr Gastroenterol Nutr 1990;
10:193-8.
19. Frühwirth M, Karmaus W, Moll-Schüler, Brösl S, Mutz
I. A prospective evaluation of community acquired
gastroenteritis in paediatric practices: Impact and dis-
ease burden of rotavirus infection. Arch Dis Child
2001;84:393-7.
20. Hegar B, Kadim M, Pasaribu A. Karakteristik
mikroorganisme saluran cerna pada anak dengan diare
akut. Maj Kedokt Indon 2004;54:367-71.
21. Yasman. Perbandingan manfaat pemberian susu semula,
susu rendah laktosa dan susu bebas laktosa pada diare
akut [thesis]. Palembang: Bagian Ilmu Kesehatan Anak
Fakultas Kedokteran Universitas Sriwijaya Palembang
1997.
22. Simakachorn N, Tonoenyai Y, Tongtan O, Varavithya
W. Randomized, double-blind clinical trial of a lactose-
free and a lactose-containing formula in dietary man-
agement of acute childhood diarrhea. J Med Assoc Thai
2004;87:641-9.
23. Duggan C, Nurko S. Feeding the gut: The scientific
basis for continued enteral nutrition during acute di-
arrhea. J Pediatr 1997;131:238-46.