Effects of probiotics on gastrointestinal symptoms, anthropometric measurements, and breastfeeding duration in infants with colic: a randomized control trial

Karaahmet, Aysu Yıldız; Dolgun, Gülümser; Özen, Metehan

doi:10.1590/1516-3180.2023.0069.R1.31052023

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ORIGINAL ARTICLE • Sao Paulo Med. J. 142 (4) • 2024 • https://doi.org/10.1590/1516-3180.2023.0069.R1.31052023 copy

Effects of probiotics on gastrointestinal symptoms, anthropometric measurements, and breastfeeding duration in infants with colic: a randomized control trial

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

BACKGROUND:

Infantile colic has a multifactorial etiology. Recent studies have suggested that probiotics may be effective in its management.

OBJECTIVE:

This study was carried out to evaluate the effect of the Actiregularis strain (5×10⁶ cfu\ml) included in maternal nutrition on gastrointestinal problems, growth development, and breastfeeding outcomes in infantile colic.

DESIGN AND SETTING:

The study was a randomized controlled trial conducted in the neonatal outpatient clinic of a training and research hospital in Turkey.

METHODS:

A probiotic drink containing the Actiregularis (5×10⁶ cfu\ml) strain was added to the diet of mothers in the probiotics group once daily for 15 consecutive days. Data were collected for each infant’s 0th (birth), 1st, 4th, and 6th months.

RESULTS:

Infants whose mothers were administered Actiregularis for 15 days had decreased crying intensity (P = 0.000). When the difference in breastfeeding rates between the groups was significant at the 4th and 6th months (P = 0.044; P = 0.035). There was no difference in anthropometric values except the babies’ weights at the 6th month. (P < 0.001).

CONCLUSION:

Infants treated with Actiregularis, which was added to their mothers’ diet for 15 days, showed a decrease in the frequency of crying, and the difference in breastfeeding rates between the groups was significant at the 4th and 6th months. There was no difference in anthropometric values except the babies’ weights at the 6th month.

CLINICAL TRIALS REGISTRATION:

NCT04374955 (https://clinicaltrials.gov/ct2/show/).

KEYWORDS (MeSH terms):
Colic; Crying; Probiotics; Maternal nutritional physiological phenomena

AUTHORS’ KEYWORDS:
Fussing; Excessive crying; Infants; Complementary and alternative medicine

		Probiotics		Control		Test Value	P
		n	%	n	%	Test Value	P
Mother’s age	24 years and under	7	46.7	8	50.0	0.034^ χ= Chi-square analysis.	0.853
25.58 ± 5.04	25 years and older	8	53.3	8	50.0	0.034^ χ= Chi-square analysis.	0.853
Mother’s weight	9 pounds and less	7	46.7	8	50.0	0.034^ χ= Chi-square analysis.	0.569
10.35 ± 5.90	10 pounds and more	8	53.3	8	50.0	0.034^ χ= Chi-square analysis.	0.569
Postnatal age of the baby	Day	30.20 ± 2.21		29.56 ± 1.82		0.878^ χ= Chi-square analysis.	0.387
Gestational age	Week	39.32 ± 0.87		39.10 ± 1.16		0.591^ χ= Chi-square analysis.	0.559
Sex of the baby	Girl	10	66.7	0.059^ χ= Chi-square analysis.	0.553	0.059^ χ= Chi-square analysis.	0.553
Sex of the baby	Boy	5	33.3	6	37.5	0.059^ χ= Chi-square analysis.	0.553
Sum		15	100.0	16	100.0

		$\bar{X}$ ± SD [Min-Max]	Test value	P
1	Intervention	9.93 ± 0.26 [9.00–10.00]	112.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.770
1	Control	10.00 ± 0.00[10.00–10.00]		0.770
2	Intervention	9.87 ± 0.35 [9.00–10.00]	111.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.740
2	Control	9.94 ± 0.25[9.00–10.00]		0.740
3	Intervention	9.73 ± 0.46[9.00–10.00]	95.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.338
3	Control	9.94 ± 0.25[9.00–10.00]		0.338
4	Intervention	9.33 ± 0.49[9.00–10.00]	62.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.021 ^* *P < 0.05;
4	Control	9.81 ± 0.40[9.00–10.00]		0.021 ^* *P < 0.05;
5	Intervention	9.00 ± 0.85[8.00–10.00]	70.00^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.049 ^* *P < 0.05;
5	Control	9.63 ± 0.62[8.00–10.00]		0.049 ^* *P < 0.05;
6	Intervention	8.60 ± 0.83[7.00–10.00]	39.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.001 ^* *P < 0.05;
6	Control	9.63 ± 0.62[8.00–10.00]		0.001 ^* *P < 0.05;
7	Intervention	7.93 ± 1.03[7.00–10.00]	34.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
7	Control	9.38 ± 0.62[8.00–10.00]		0.000 ^* *P < 0.05;
8	Intervention	7.20 ± 1.01[6.00–9.00]	13.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
8	Control	9.13 ± 0.62[8.00–10.00]		0.000 ^* *P < 0.05;
9	Intervention	6.80 ± 1.15[5.00–8.00]	9.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
9	Control	9.06 ± 0.68[8.00–10.00]		0.000 ^* *P < 0.05;
10	Intervention	6.27 ± 1.22[5.00–8.00]	9.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
10	Control	8.94 ± 0.85[7.00–10.00]		0.000 ^* *P < 0.05;
11	Intervention	5.60 ± 0.99[4.00–7.00]	3.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
11	Control	8.50 ± 0.82[7.00–10.00]		0.000 ^* *P < 0.05;
12	Intervention	5.33 ± 1.18[4.00–7.00]	4.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
12	Control	8.19 ± 0.83[7.00–10.00]		0.000 ^* *P < 0.05;
13	Intervention	5.13 ± 0.99[4.00–7.00]	1.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
13	Control	8.38 ± 0.89[7.00–10.00]		0.000 ^* *P < 0.05;
14	Intervention	4.73 ± 0.70[4.00–6.00]	0.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
14	Control	8.31 ± 0.95[7.00–10.00]		0.000 ^* *P < 0.05;
15	Intervention	3.93 ± 0.70[3.00–5.00]	0.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X = mean; SD = standard deviation.	0.000 ^* *P < 0.05;
15	Control	8.19 ± 1.22[6.00–10.00]		0.000 ^* *P < 0.05;

		$\bar{X}$ ± SD [Min-Max]	Test value	P
1	Intervention	1.80 ± 1.15[1–5]	82.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.140
1	Control	1.19 ± 0.40[1–2]		0.140
2	Intervention	2.13 ± 1.81[0–7]	61.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.019 ^* *P < 0.05;
2	Control	0.81 ± 0.83[0–2]		0.019 ^* *P < 0.05;
3	Intervention	2.00 ± 1.36[0–4]	64.00^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.027 ^* *P < 0.05;
3	Control	0.88 ± 0.62[0–2]		0.027 ^* *P < 0.05;
4	Intervention	2.00 ± 1.85[0–8]	75.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.078
4	Control	1.06 ± 0.85[0–3]		0.078
5	Intervention	1.93 ± 1.83[0–7]	99.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.423
5	Control	1.19 ± 0.75[0–3]		0.423
6	Intervention	1.73 ± 1.49[0–6]	66.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.033 ^* *P < 0.05;
6	Control	0.75 ± 0.77[0–2]		0.033 ^* *P < 0.05;
7	Intervention	1.93 ± 1.39[1–5]	80.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.119
7	Control	1.13 ± 0.89[0–3]		0.119
8	Intervention	2.13 ± 1.46[0–5]	58.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.014 ^* *P < 0.05;
8	Control	0.88 ± 0.96[0–3]		0.014 ^* *P < 0.05;
9	Intervention	2.20 ± 1.61[0–6]	75.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.078
9	Control	1.19 ± 0.75[0–3]		0.078
10	Intervention	1.93 ± 1.22[1–5]	63.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.024 ^* *P < 0.05;
10	Control	0.94 ± 0.68[0–2]		0.024 ^* *P < 0.05;
11	Intervention	1.87 ± 1.41[0–5]	86.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.188
11	Control	1.13 ± 0.81[0–3]		0.188
12	Intervention	2.07 ± 1.53[0–5]	77.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.093
12	Control	1.13 ± 0.96[0–3]		0.093
13	Intervention	2.07 ± 1.53[0–5]	75.000^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.078
13	Control	1.06 ± 0.77[0–3]		0.078
14	Intervention	1.80 ± 1.32[0–5]	66.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.033 ^* *P < 0.05;
14	Control	0.81 ± 0.66[0–2]		0.033 ^* *P < 0.05;
15	Intervention	1.93 ± 1.28[1–5]	83.500^ Mann Whitney U test. Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.151
15	Control	1.19 ± 0.66[0–3]		0.151

		Min	Max	Median	$\bar{X}$	SD	Test value	P
Birth weight	Probiotics	2755.00	3790.00	3115.00	3182.00	280.95	-0.706^ Independent t-test;	0.486
Birth weight	Control	2250.00	4015.00	3382.50	3293.44	547.24	-0.706^ Independent t-test;	0.486
1^st month	Probiotics	3300.00	5000.00	4100.00	4089.67	501.53	-0.278^ Independent t-test;	0.783
1^st month	Control	3400.00	5200.00	4200.00	4139.38	492.62	-0.278^ Independent t-test;	0.783
4^th month	Probiotics	5280.00	7200.00	6450.00	6383.33	456.41	1.746^ Independent t-test;	0.091
4^th month	Control	4800.00	7420.00	5925.00	6008.13	705.01	1.746^ Independent t-test;	0.091
6^th month	Probiotics	6450.00	8800.00	7850.00	7699.33	651.15	50.500^* *Mann Whitney U test; Min = minimum; Max = Maximum; X < in = mean; SD = standard deviation.	0.005 ^* *P < 0.05;
6^th month	Control	1050.00	8800.00	6800.00	6680.63	1675.19		0.005 ^* *P < 0.05;
Birth Size Measure	Probiotics	46.00	52.00	51.00	50.27	1.87	-0.371^ Independent t-test;	0.713
Birth Size Measure	Control	47.00	55.00	50.00	50.56	2.50	-0.371^ Independent t-test;	0.713
1st month	Probiotics	50.00	56.00	54.00	53.33	2.09	0.098^ Independent t-test;	0.923
1st month	Control	49.00	58.00	53.00	53.25	2.59	0.098^ Independent t-test;	0.923
4^th month	Probiotics	59.00	69.00	65.00	63.87	2.95	1.798^ Independent t-test;	0.083
4^th month	Control	57.00	68.00	62.00	61.88	3.20	1.798^ Independent t-test;	0.083
6^th month	Probiotics	64.00	73.00	71.00	69.93	2.76	1.395^ Independent t-test;	0.174
6^th month	Control	64.00	74.00	69.00	68.56	2.71	1.395^ Independent t-test;	0.174
Head Circumference on Birth	Probiotics	33.00	36.00	35.00	34.87	0.64	114.500^ Independent t-test;	0.830
Head Circumference on Birth	Control	33.00	37.00	35.00	34.88	0.89	114.500^ Independent t-test;	0.830
1^st month	Probiotics	35.00	38.00	36.00	36.43	0.86	120.000^ Independent t-test;	1.000
1^st month	Control	35.00	38.00	36.50	36.44	0.81	120.000^ Independent t-test;	1.000
4^th month	Probiotics	38.00	40.00	39.00	38.60	0.63	99.000^ Independent t-test;	0.423
4^th month	Control	38.00	40.00	39.00	38.81	0.66	99.000^ Independent t-test;	0.423
6^th month	Probiotics	39.00	43.00	41.00	40.93	1.10	113.000^ Independent t-test;	0.800
6^th month	Control	39.00	42.00	41.00	41.00	0.89	113.000^ Independent t-test;	0.800

Variables		Probiotics		Control		Test Value	P
Variables		n	%	n	%	Test Value	P
4^th month nutritional status	Breast milk only	14	93.3	9	56.3	5.727^* ** Chi square analysis.	0.044 ^* *P < 0.05;
	Breast milk + formula	1	6.7	5	31.2
	Just food	0	0.0	2	12.5
6^th month nutritional status	Breast milk only	1	6.7	0	0.0	7.642^ Chi square analysis.	0.035 ^* *P < 0.05;
	Just food	0	0.0	1	6.2
	Breast milk + additional food	14	93.3	10	62.5
	Additional food only	0	0.0	5	31.3
Cessation of breastfeeding	Yes	2	13.3	6	37.5	2.362^ Chi square analysis.	0.220
Cessation of breastfeeding	No	13	86.7	10	62.5	2.362^ Chi square analysis.	0.220
Time of initiation of additional food	4^th month	0	0.0	3	18.8	8.471^ Chi square analysis.	0.018 ^* *P < 0.05;
	5^th month	4	26.7	9	56.2
	6^th month	10	66.6	4	25.0
	7^th month	1	6.7	0	0.0
Sum		15	100.0	16	100.0

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[1] Address for correspondence: Aysu Yıldız Karaahmet, Department of Midwifery, Halic University School of Health Sciences, 82, Imrahor Street, Sütlüce Neighborhood, Beyoğlu İstanbul, 05414679620, Turkey, Tel. 05414679620, E-mail: aysuyildiz@halic.edu.tr